Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods

Obesity Clinical Trial

Official title: Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Obesity
• Weight Loss

• NCT number: NCT04773795
• Study type: Interventional
• Source: Nitinotes Surgical Ltd.
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Completion date: July 3, 2023