Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT04773795
Brief Summary:
A multicenter, prospective, single-arm, open-label, controlled clinical trial aimed to evaluate the safety and effectiveness of the EndoZip system procedure, coupled with lifestyle modifications, for weight reduction in obese patients with BMI of 30-40 kg/m2.
Detailed Description:
study will include up to 45 (10-20 patients per site), ages of 21 -70 of obese patients who failed to reduce weight with non-surgical weight-loss methods.
The duration for each participant will be 12 months and will include the following follow up visits and procedures:
* Office visits: screening, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s)
* Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s)
* Endoscopy procedure: baseline, 2 and 6 months post EndoZip procedure
* Motility evaluation by Gastric Emptying Breath Test (GEBT): baseline, 6 months
* Physical examination, vital signs, waist circumference and BMI: baseline, 1 week, 1, 2, 4, 6, 8, 10 and 12 months
* Blood tests: baseline,2, 6 and 12 months
* IWQOL-Lite: baseline, 2, 6 and 12 months
* Psychological health questionnaire-9 (PHQ-9) :baseline
* Sleep Apnea (only for the relevant population): baseline 2, 6 and 12 months
The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).
Study:
NCT04773795
Study Brief:
Protocol Section:
NCT04773795