A feasibility study using cadaver: Efficacy and safety of the novel automatic urinary catheterization device.
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ABSTRACT:
SUBMITTER: Kang S
PROVIDER: S-EPMC6319984 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThe aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.MethodsA multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight.ResultsAcross all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events.ConclusionsThe self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.
| S-EPMC7720247 | biostudies-literature
Project description:ObjectiveTo evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI)-guided prostate biopsy using a novel robotic device.MethodsMrBot is an MRI-safe robotic device constructed entirely with nonconductive, nonmetallic, and nonmagnetic materials and developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of a direct MRI-guided biopsy with MrBot and to determine its targeting accuracy. Men with elevated prostate-specific antigen levels, prior negative prostate biopsies, and cancer-suspicious regions (CSRs) on MRI were enrolled in the study. Biopsies targeting CSRs, in addition to sextant locations, were performed.ResultsFive men underwent biopsy with MrBot. Two men required Foley catheter insertion after the procedure, with no other complications or adverse events. Even though this was not a study designed to detect prostate cancer, biopsies confirmed the presence of a clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55 mm and a precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site.ConclusionRobot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that a clinically significant prostate cancer (≥5-mm radius, 0.5 cm3) depicted in MRI may be accurately targeted. Direct confirmation of needle placement in the CSR may present an advantage over fusion-based technology and gives more confidence in a negative biopsy result. Additional study is warranted to evaluate the efficacy of this approach.
| S-EPMC7226682 | biostudies-literature
Project description:BackgroundInadvertent perioperative hypothermia (IPH) leads to surgical complications and increases length of stay. IPH rates are high with the current standard of care, forced air warming (FAW). Our hypothesis is that a prototype thermal compression device that heats the popliteal fossa and soles of the feet, with lower leg compression, increases perioperative temperatures and reduces IPH compared to the current standard of care.MethodsThirty six female breast surgery patients, at a tertiary academic hospital, were randomized to the device or intraoperative FAW (stage I) with a further 18 patients randomized to the device with a single heating area only (stage II, popliteal fossa or sole of the feet). Stage I: 37 patients recruited (final 36). Stage II: 18 patients recruited (final 18).Inclusion criteriageneral anesthesia with esophageal monitoring for over 30 min, legs available and able to fit the device and no contraindications to leg heating or compression. The intervention was: Stage I: Investigational prototype thermal compression device (full device group) or intraoperative FAW. Stage II: Device with only a single heating location. Primary outcomes were perioperative temperatures and incidence of IPH. Secondary outcomes were local skin temperature, general and thermal comfort scores and presence of perioperative complications, including blood loss.ResultsMean temperatures in the full device group were significantly higher than the FAW group in the pre-operative (36.7 vs 36.4 °C, p < 0.001), early intraoperative (36.3 vs 35.9 °C, p < 0.001), intraoperative (36.6 vs 36.2 °C, p < 0.001) and postoperative periods (36.8 vs 36.5 °C, p < 0.001). The incidence of IPH in the device group was also significantly lower (16.7% vs 72.0%, p = 0.001). Thermal comfort scores were significantly higher in the full device group and hypothermia associated wound complications were higher in the FAW group.ConclusionsThe thermal compression device is feasible and has efficacy over the FAW. Further studies are recommended to investigate clinically significant outcomes.Trial registrationclinicaltrials.gov ( NCT02155400 ).
| S-EPMC5553896 | biostudies-literature
Project description:BackgroundThere is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages.MethodsTen consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance.ResultsNo safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group.ConclusionRemote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.
| S-EPMC8453715 | biostudies-literature
Project description:BackgroundWe investigated the feasibility of aneurysm sac embolization using a novel self-expanding porous shape memory polymer (SMP) device during endovascular aortic abdominal or thoracic aneurysm repair (EVAR).MethodsRetrospective analysis of consecutive patients treated at 2 centers in Germany. Patients were treated from January 2019 to July 2021 with follow-up at 7 days and 3, 6, and 12 months. Aneurysm sacs were implanted with SMP devices immediately following endograft placement during the same procedure. Primary endpoint was technically successful SMP-device deployment into the aneurysm sac outside the endograft. Secondary endpoints were changes in aneurysm volume and associated complications (e.g., endoleaks).ResultsWe included 18 patients (16 males), aged 72 ± 9 years, achieving 100% technical success. Mean preprocedure aortic aneurysm sac volume was 195 ± 117 mL with a perfused aneurysm volume of 97 ± 60 mL. A mean of 24 ± 12 SMP devices per patient were used (range 5-45, corresponding to 6.25-56.25 mL expanded embolic material volume). All evaluable patients exhibited sac regression except 2 patients yet to reach 3-month follow-up. At mean 11 ± 7 months (range 3-24), change in aneurysm volume from baseline was -30 ± 21 mL (p < 0.001). In 8 patients, aneurysm regression was observed despite type 2 endoleaks in 6 and type 1A endoleaks in 2, none of them requiring further intervention to date. No morbidity or mortality related to this treatment occurred.ConclusionsSMP devices for aortic aneurysm sac embolization during endovascular repair appear feasible and safe in this small case series. Prospective studies are needed.Key points• Shape memory polymer is a novel, self-expanding, porous, and radiolucent embolic device material. • Aortic aneurysm sacs were treated with polymer devices immediately following endograft placement. • Aortic aneurysm sac regression was observed in all patients with over 3-month follow-up. • Aortic aneurysm sac regression was observed even in the presence of endoleaks.
| S-EPMC10068687 | biostudies-literature
Project description:As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). Although a number of devices for EIMC are prequalified by the World Health Organization, evaluation of additional devices can provide policy-makers and clinicians the information required to make informed decisions. We undertook a field evaluation of the safety and acceptability of the AccuCirc device in Kisumu County, Kenya.Procedures were performed by four trained clinicians in two public facilities. Participants were recruited from surrounding public health facilities through informational talks at antenatal clinics, maternity wards, and maternal neonatal child health clinics. Healthy infants ages 0-60 days, with no penile abnormality, without a family history of bleeding disorder, with current weight-for-age within -2 Z-scores of WHO growth standards, and whose mother was at least 16 years of age were eligible for EIMC. The procedure was performed after administration of a penile dorsal nerve block using 2% lidocaine and administration of Vitamin K. The mother was given post-operative instructions on wound care and asked to remain in the clinic with the baby for an observational period of one hour, during which a face-to-face questionnaire was administered.Of 1259 babies screened, 704 were enrolled and circumcised. Median age of the infants was 16 days (IQR: 7-32.5) and of the mothers was 26 years (IQR: 22-30). Median time for the procedure was 19 minutes (IQR: 15-23). There were no serious adverse events (AE), and 20 (2.8%) moderate AEs, all of which were due to bleeding that required application of one to three sutures. There were 22 (3.8%) procedures in which the device did not fully incise the entire circumference of the foreskin and had to be completed using sterile scissors. 89.9% of mothers had knowledge of EIMC, but few (8.1%) had any knowledge of devices used for EIMC. Protection against HIV/AIDS was the most cited reason to circumcise a baby (65.3%), while the baby being ill (38.1%) and pain (34.4%) were the most cited barriers to uptake. 99% of mothers were "very satisfied" or "completely satisfied" with the procedure.This evaluation of the AccuCirc device is the largest to date and indicates that the device is safe and acceptable, achieving high levels of parental satisfaction. The AccuCirc device should be considered for WHO prequalification to increase options for safe and sustainable provision of EIMC.
| S-EPMC5812570 | biostudies-literature
Project description:BackgroundThe Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken.MethodsThe primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A'Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%.DiscussionThe data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth.Trial registrationISRCTN registration: 38829082 (prospectively registered July 26, 2019).
| S-EPMC7977305 | biostudies-literature
Project description:Trabeculectomy has been the traditional primary surgical therapy for open-angle glaucoma. While trabeculectomy is effective in lowering intraocular pressure, complications associated with the procedure have motivated the development of alternative techniques and devices, including the EX-PRESS Glaucoma Filtration Device. This review describes the efficacy, safety, complication rates, and potential advantages and disadvantages of the EX-PRESS Glaucoma Filtration Device. EX-PRESS implantation is technically simpler compared with that of trabeculectomy, with fewer surgical steps. Vision recovery has been more rapid after EX-PRESS implantation compared with trabeculectomy. Intraocular pressure variation is lower during the early postoperative period, indicating a more predictable procedure. While efficacy of the EX-PRESS implant has been comparable to trabeculectomy, postoperative complications appear less common after EX-PRESS implantation compared with trabeculectomy. The EX-PRESS Glaucoma Filtration Device appears to be safe and effective in the surgical management of open-angle glaucoma.
| S-EPMC4562650 | biostudies-literature
Project description:Incidental radiation exposure to the heart during lung cancer radiotherapy is associated with radiation-induced heart disease and increased rates of mortality. By considering the respiratory-induced motion of the heart it is possible to create a radiotherapy plan that results in a lower overall cardiac dose. This approach is challenging using current clinical practices: manual contouring of the heart is time consuming, and subject to inter- and intra-observer variability. In this work, we investigate the feasibility of our previously developed, atlas-based, automatic heart segmentation tool to delineate the heart in four-dimensional x-ray computed tomography (4D-CT) images. We used a dataset comprising 19 patients receiving radiotherapy for lung cancer, with 4D-CT imaging acquired at 10 respiratory phases and with a maximum intensity projection image generated from these. For each patient, one of four experienced radiation oncologists contoured the heart on each respiratory phase image and the maximum intensity image. Automatic segmentation of the heart on these same patient image sets was achieved using a leave-one-out approach, where for each patient the remaining 18 were used as an atlas set. The consistency of the automatic segmentation relative to manual contouring was evaluated using the Dice similarity coefficient (DSC) and mean absolute surface-to-surface distance (MASD). The DSC and MASD are comparable to inter-observer variability in clinically acceptable whole heart delineations (average DSC > 0.93 and average MASD < 2.0 mm in all the respiratory phases). The comparison between automatic and manual delineations on the maximum intensity images produced an overall mean DSC of 0.929 and a mean MASD of 2.07 mm. The automatic, atlas-based segmentation tool produces clinically consistent and robust heart delineations and is easy to implement in the routine care of lung cancer patients.
| S-EPMC7808597 | biostudies-literature
Project description:BackgroundThe traditional radial approach (RA) is recommended as the standard method for coronary angiography (CAG), while a distal RA (DRA) has been recently used for CAG.AimTo assess the efficacy and safety of the DRA vs RA during CAG.MethodsThe following databases were searched through December 2020: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the World Health Organization International Clinical Trials Platform Search Portal, and ClinicalTrials.gov. Individual randomized-controlled trials for adult patients undergoing cardiac catheterization were included. The primary outcomes were the successful cannulation rate and the incidence of radial artery spasm (RAS) and radial artery occlusion (RAO). Study selection, data abstraction and quality assessment were independently performed using the Grading of Recommendations, Assessment, Development, and Evaluation approach.ResultsThree randomized control trials and 13 registered trials were identified. The two approaches showed similar successful cannulation rates [risk ratio (RR) 0.90, 95% confidence interval (CI): 0.72-1.13]. The DRA did not decrease RAS (RR 0.43, 95%CI: 0.08-2.49) and RAO (RR 0.48, 95%CI: 0.18-1.29). Patients with the DRA had a shorter hemostasis time in comparison to those with the RA (mean difference -6.64, 95%CI: -10.37 to -2.90). The evidence of certainty was low.ConclusionFor CAG, the DRA would be safer than the RA with comparable cannulation rates. Given the limited data, additional research, including studies with standard protocols, is necessary.
| S-EPMC8173336 | biostudies-literature