Browse
Submit Data
Databases
API
Help

Dataset Information

8 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Feasibility study of a single-use balloon-assisted robotic colonoscope in healthy volunteers.

ABSTRACT: Background and study aims Despite its widespread adoption, colonoscope still has its limitations. Advancement is often limited by the looping of colon. The isolation of SARS-CoV-2 in stool raises concern for the risk of disease transmission. A single-use robotic colonoscope, the NISInspire-C System, that features a balloon-suction anchorage mechanism was developed to address these. Methods The NISInspire-C balloons are designed to provide anchorage for straightening of the colon during advancement. Angulation at the bending section is tendon-wire driven by servo mechanisms integrated into a robotic control console. This was a pilot, prospective trial to evaluate the safety and feasibility of this system. Healthy volunteers underwent examination with the NISInspire-C, followed by the conventional colonoscope. The procedure time, cecal intubation rates (CIR), complications, and level of pain were measured. Results A total of 19 subjects underwent the examination. The cecal intubation rate was 89.5 % (17/19) and the overall time-to-cecum was 26.3 minutes (SD: 17.9 mins). There were no procedure-related complications. Polyps were detected in seven of 19 (36.8 %) subjects during the NISInspire-C procedure. Three more subjects were found to have adenomatous polyps with the conventional colonoscope. There was minimal variation in level of pain during the procedures with the two colonoscopes. Conclusion The single-use robotic colonoscope NISInspire-C is a safe and feasible alternative to the conventional colonoscope. Further technical refinement is needed to improve the CIR. This study was limited by its small sample size.

SUBMITTER: Foo CC

PROVIDER: S-EPMC7969132 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Json Xml

Similar Datasets

High cecal intubation rates with a new computer-assisted colonoscope: a feasibility study.

Project description:OBJECTIVES: The acceptability of colonoscopy as a screening test is limited by several factors including patient discomfort. A new self-propelled colonoscope, the Invendo SC20 (Invendo Medical GmbH), may be helpful in reducing sedation. It consists of a sheathed endoscope contained within an "inverted sleeve," and having an instrument channel and an electrohydraulic bendable tip; it is steered using a handheld device and propelled by a motorized drive unit. This study assessed the safety and efficacy of this new endoscope in volunteers undergoing colorectal cancer (CRC) screening. METHODS: Paid healthy volunteers aged 50-70 years and eligible for screening colonoscopy were included. Total colonoscopy using carbon dioxide insufflation or water instillation on demand was attempted, with all procedures being started without sedation. The main outcome parameters were safety and the cecal intubation rate. RESULTS: A total of 61 volunteers participated (34 men and 27 women; mean age 57.5 years). The cecum was reached in 60 volunteers (cecal intubation rate of 98.4%). The median time to reach the cecum was 15 min (range 7-53.5). Sedation was given in three individuals (4.9%). On withdrawal (median time 15 min), the material for histological evaluation was obtained from 33 polyps (mean size 4.8 mm) in 23 people by biopsy forceps or snare. No device-related complications were encountered. CONCLUSIONS: A new computer-assisted colonoscope, controlled using a handheld device, showed excellent cecal intubation rates during screening examinations, with sedation required in only ~ 5% of screenees. Further clinical and comparative studies are warranted.

| S-EPMC3185926 | biostudies-other

Robotic-assisted interval cytoreductive surgery in ovarian cancer: a feasibility study.

Project description:ObjectiveThe primary objective was to assess the feasibility of robotic-assisted interval cytoreductive surgery for achieving complete cytoreduction for patients with advanced-stage ovarian cancer. The secondary objective was to examine the perioperative outcomes.MethodsA retrospective study of 12 patients with stage IIIC or IV ovarian, fallopian tube, and primary peritoneal carcinoma who underwent interval cytoreductive surgery after neo-adjuvant chemotherapy.ResultsOptimal cytoreduction was achieved in 100% of selected patients. Complete cytoreductive surgery was achieved in 75% of patients. The estimated mean blood loss was 100 mL. The median length of hospital stay was 2 days. Perioperative complication and 30-day readmission rates were 8.3% (1 patient). The median follow-up time was 9.5 months.ConclusionRobotic-assisted interval cytoreductive surgery in ovarian cancer is safe and feasible and may be an alternative to standard laparotomy in selected patients.

| S-EPMC7073361 | biostudies-literature

Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Project description:This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System, followed immediately by a conventional colonoscope (CC). Each trial subject will undergo colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of procedural pain experienced by subjects will also be explored.

| 2307836 | ecrin-mdr-crc

A single ascending dose study of single-stranded oligodeoxyribonucleotide RO7062931 in Chinese healthy volunteers.

Project description:RO7062931 is an N-acetylgalactosamine (GalNAc)-conjugated single-stranded oligodeoxyribonucleotide complementary to hepatitis B virus RNA. GalNAc conjugation targets the liver through the asialoglycoprotein receptor (ASGPR). This phase I single ascending dose (SAD) study evaluated the safety, tolerability, and pharmacokinetics of RO7062931 in Chinese healthy volunteers. There were four SAD cohorts (0.3, 1.0, 2.0, and 4.0 mg/kg), in each of which healthy volunteers were randomized to a single subcutaneous (s.c.) injection of RO7062931 or matching placebo in a 4:1 ratio. Placebo recipients were pooled as one treatment group for safety assessments. A total of 41 healthy Chinese men received one dose of RO7062931 (n = 33) or placebo (n = 8) and completed the study (85-day follow-up). Adverse events (AEs) were reported in 22 of 33 (66.6%) RO7062931 recipients (n = 80 treatment-related) and seven of eight (87.5%) placebo recipients (n = 1 treatment-related). Apart from two moderate-intensity AEs, all AEs were mild. The most frequently reported AEs were influenza, injection-related reactions, and headache. Dose-proportional increases in plasma RO7062931 exposure were observed between the 0.3 and 1.0 mg/kg doses, whereas a supra-dose-proportional increase occurred at doses greater than or equal to 2.0 mg/kg, along with a marked increase in urinary excretion. Single s.c. dose of RO7062931 up to 4.0 mg/kg were safe and well-tolerated in healthy Chinese volunteers. Pharmacokinetic data suggested that ASGPR saturation had commenced between doses of 2.0 and 4.0 mg/kg. Results were broadly consistent with observations in primarily White subjects in the global first-in-human study of RO7062931.

| S-EPMC10339693 | biostudies-literature

Cutaneous Respirometry as Novel Technique to Monitor Mitochondrial Function: A Feasibility Study in Healthy Volunteers.

Project description:The protoporphyrin IX-triplet state lifetime technique (PpIX-TSLT) is proposed as a potential clinical non-invasive tool to monitor mitochondrial function. This technique has been evaluated in several animal studies. Mitochondrial respirometry allows measurement in vivo of mitochondrial oxygen tension (mitoPO2) and mitochondrial oxygen consumption (mitoVO2) in skin. This study describes the first use of a clinical prototype in skin of humans.The clinical prototype was tested in 30 healthy volunteers. A self-adhesive patch containing 2 mg 5-aminolevulinic acid (ALA) was applied on the skin of the anterior chest wall (sternal) for induction of mitochondrial protoporphyrin IX and was protected from light for 5 h. MitoPO2 was measured by means of oxygen-dependent delayed fluorescence of protoporphyrin IX. MitoVO2 was determined by dynamic mitoPO2 measurements on the primed skin, while locally blocking oxygen supply by applying local pressure with the measurement probe. MitoPO2 was recorded before and during a 60-s period of compression of the microcirculation, at an interval of 1 Hz. Oxygen consumption (i.e. the local oxygen disappearance rate) was calculated from the decay of the mitoPO2 slope.Oxygen-dependent delayed fluorescence measurements were successfully performed in the skin of 27 volunteers. The average value (± SD) of mitoPO2 was 44 ± 17 mmHg and mean mitoVO2 values were 5.8 ± 2.3 and 6.1 ± 1.6 mmHg s-1 at a skin temperature of 34°C and 40°C, respectively. No major discomfort during measurement and no long-term dermatological abnormalities were reported in a survey performed 1 month after measurements.These results show that the clinical prototype allows measurement of mitochondrial oxygenation and oxygen consumption in humans. The development of this clinically applicable device offers opportunities for further evaluation of the technique in humans and the start of first clinical studies.

| S-EPMC4959702 | biostudies-literature

Transoral robotic-assisted thyroidectomy with central neck dissection: preclinical cadaver feasibility study and proposed surgical technique.

Project description:UnlabelledRecently, a transoral robotic-assisted technique to access the thyroid gland has been introduced. Despite the advantages this approach may have over other minimally invasive and robotic-assisted techniques, we found that the placement of the camera through the floor of mouth led to restricted freedom of movement. We describe our modification to this technique to overcome this problem. In a study using two fresh human cadavers, the camera port of the da Vinci robot was placed in the midline oral vestibule instead of the floor of the mouth. A transoral thyroidectomy and central neck dissection was successfully performed. Our modification led to an unfettered view of the central neck and allowed for a total thyroidectomy and central neck dissection. Our modification of transoral robotic-assisted thyroidectomy provides superior access to the central compartment of the neck over other robotic-assisted thyroidectomy techniques.Electronic supplementary materialThe online version of this article (doi:10.1007/s11701-011-0287-2) contains supplementary material, which is available to authorized users.

| S-EPMC3214254 | biostudies-literature

Orally administered moxifloxacin prolongs QTc in healthy Chinese volunteers: a randomized, single-blind, crossover study.

Project description:AIM: To investigate the QT/QTc effects of orally administered moxifloxacin in healthy Chinese volunteers. METHODS: This was a single-blinded, randomized, single-dose, placebo-controlled, two-period cross-over study. A total of 24 healthy Chinese volunteers were enrolled, randomly assigned to two groups: one group received moxifloxacin (400 mg, po) followed by placebo with a 7-d interval, another group received placebo followed by moxifloxacin with a 7-d interval. On the days of dosing, 12-lead 24 h Holter ECGs were recorded and evaluated by an ECG laboratory blind to the treatments. Blood samples were collected to determine plasma concentrations of moxifloxacin. RESULTS: The orally administered moxifloxacin significantly prolonged the mean QTc at all time points except 0.5 h post-dose. The largest time-matched difference in the QTcI was 8.35 ms (90% CI: 5.43, 11.27) at 4 h post-dose. The peak effect on QTcF was 9.35 ms (90% CI: 6.36, 12.34) at 3 h post-dose. A pharmacokinetic-QTc model suggested a 2.084 ms increase in the QTc interval for every 1000 ng/mL increase in plasma concentration of moxifloxacin. In addition, the orally administered moxifloxacin was well tolerated by the subjects. CONCLUSION: Orally administered moxifloxacin significantly prolongs QTc, which supports its use as a positive control in ICH-E14 TQT studies in Chinese volunteers.

| S-EPMC4387299 | biostudies-other

Feasibility and safety of robotic-assisted total pancreatectomy: a pilot western series.

Project description:This study was designed to demonstrate non-inferiority of robot-assisted total pancreatectomy (RATP) to open total pancreatectomy (OPT) based on an intention-to-treat analysis, having occurrence of severe post-operative complications (SPC) as primary study endpoint. The two groups were matched (2:1) by propensity scores. Assuming a rate of SPC of 22.5% (non-inferiority margin: 15%; α: 0.05; β: 0.20; power: 80%), a total of 25 patients were required per group. During the study period (October 2008-December 2019), 209 patients received a total pancreatectomy. After application of exclusion and inclusion criteria, matched groups were extracted from an overall cohort of 132 patients (OPT: 107; RATP: 25). Before matching, the two groups were different with respect to prevalence of cardiac disease (24.3% versus 4.0%; p = 0.03), presence of jaundice (45.8% versus 12.0%; p = 0.002), presence of a biliary drainage (23.4% versus 0; p = 0.004), history of weight loss (28.0% versus 8.0%; p = 0.04), and vein involvement (55.1% versus 28.0%) (p = 0.03). After matching, the two groups (OTP: 50; RATP: 25) were well balanced. Regarding primary study endpoint, SPC developed in 13 patients (26.0%) after OTP and in 6 patients (24.0%) after RATP (p = 0.85). Regarding secondary study endpoints, RATP was associated with longer median operating times [475 (408.8-582.5) versus 585 min (525-637.5) p = 0.003]. After a median follow-up time of 23.7 months (10.4-71), overall survival time [22.6 (11.2-81.2) versus NA (27.3-NA) p = 0.006] and cancer-specific survival [22.6 (11.2-NA) versus NA (27.3-NA) p = 0.02] were improved in patients undergoing RATP. In carefully selected patients, robot-assisted total pancreatectomy is non-inferior to open total pancreatectomy regarding occurrence of severe post-operative complications.

| S-EPMC8184722 | biostudies-literature

Dual-operator technique by use of digital cholangioscope through colonoscope-assisted ERCP in a patient with altered anatomy.

Project description: Not available

| S-EPMC5990376 | biostudies-literature

Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers.

Project description:BACKGROUND: This phase I study was designed to determine the bioavailability and bioequivalence of 400 mg Eudorlin extra* (Ibuprofen) in comparison to two reference formulations (400 mg Nurofen forte and 400 mg Migränin after single dose administration under fasting conditions in healthy subjects. Therefore the design of a randomized, open label, multiple sequence cross-over study with a wash-out period of 7-10 days was used. RESULTS: AUC(0-t)(last) and AUC(0-infinity) (90%CI) were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the EMEA. Cmax (90%CI) was within the EMEA acceptance range of 75 to 133%. Detailed analyses showed that Cmax of Eudorlin extra was higher than that of Nurofen forte (36.62 vs. 32.92 microg/ml; p = 0.0014) and that of Migränin (35.94 vs. 30.87 microg/ml; p < 0.0001). The time to maximum plasma concentration (tmax) was shorter with Eudorlin extra than with Nurofen forte (1.14 vs. 1.82 h; p < 0.0001) and Migränin (1.13 vs. 1.78 h; p = 0.0031). Only 1 patient experienced an adverse with possible relation to the study drug taking Migränin. CONCLUSION: It is concluded that Eudorlin extra is bioequivalent to the two reference preparations Nurofen forte and Migränin for both, the extent and the rate of absorption, after single dose administration in healthy volunteers according to the guidance of the EMEA. Within this frame, peak plasma concentrations are however reached earlier and peaks are higher compared to the reference products. * Eudorlin extra may have different brand names in different countries.

| S-EPMC2613135 | biostudies-literature

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data