Dataset Information

Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System.

ABSTRACT: BACKGROUND AND AIMS:To assess safety of the Exilis™ gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated. METHOD:In a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8?±?0.7 kg/m2) were implanted with the Exilis™ system. Amplitude of the Exilis™ system was individually set during titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks. RESULTS:The procedure was safe, and electrical stimulation was well tolerated and comfortable in all subjects. No significant differences in gastric emptying halftime (203?±?16 vs. 212?±?14 min, p?>?0.05), food intake (713?±?68 vs. 799?±?69 kcal, p?>?0.05), insulin AUC (2448?±?347 vs. 2186?±?204, p?>?0.05), and glucose AUC (41?±?2 vs.41?±?2, p?>?0.05) were found between GES ON and OFF. At week 4, 13, and 26, a significant (p?

SUBMITTER: Paulus GF

PROVIDER: S-EPMC7228902 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System.

Paulus G F GF van Avesaat M M van Rijn S S Alleleyn A M E AME Swain J M JM Abell T L TL Williams D B DB Bouvy N D ND Masclee A A M AAM

Obesity surgery 20200501 5

<h4>Background and aims</h4>To assess safety of the Exilis™ gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated.<h4>Method</h4>In a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8 ± 0.7 kg/m<sup>2</sup>) were implanted with the Exilis™ system. Amplitude of the Exilis™ ...[more]

PMID: 32133590

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Project description:BackgroundChronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Existing treatment options largely surround helping patients cope with their disease as opposed to directly suppressing tinnitus perception. The current study investigated the efficacy of electrical stimulation of the cochlea on chronic disabling tinnitus.MethodsIn this single-arm, open-label clinical trial, 22 adult subjects with severe-range asymmetric or unilateral non-pulsatile tinnitus underwent electrical stimulation of the cochlea through use of an extra-cochlear electrode positioned on the cochlear promontory. Each subject underwent 3 stimulation treatments over 3 weeks at 7-day intervals. Tinnitus severity was determined by Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus Visual Analog Scale (VAS). Inclusion criteria required subjects have no worse than moderate sensorineural hearing loss determined by pre-enrollment audiometric testing. The primary outcome was nadir post-treatment THI scores, obtained at seven timepoints following electrical stimulation, with clinically significant improvement defined as a decrease of ≥ 7.ResultsAll 22 (100%) subjects experienced clinically significant improvement in the THI during the study period with a mean decrease in scores of - 31 (95% CI - 38 to - 25) from a baseline of 48. Twenty (91%) experienced clinically significant improvement detectable on at least two of the three tinnitus survey instruments and 17 (77%) experienced clinically significant improvement detectable on all three survey instruments (i.e., THI, TFI, and VAS). Eight (36%) subjects reported either complete (THI of 0; n = 3) or near-complete (THI 1-4; n = 5) suppression of their tinnitus following a stimulation session. Thirteen (59%) subjects reported a nadir following stimulation at or below the threshold for "no or slight handicap" on the THI (≤ 16). No adverse events were observed.ConclusionsThese findings establish the foundation for the development of an extra-cochlear implantable device that delivers electrical stimulation to the cochlea for the treatment of disabling tinnitus. For patients considering device implantation, trans-tympanic cochlear promontory stimulation can facilitate patient selection. Trial Registration ClinicalTrials.gov Identifier: NCT03759834. URL: https://clinicaltrials.gov/ct2/show/NCT03759834.

Dataset Information

Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System.

Publications

Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System.

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