NCT04773795

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Nitinotes Surgical Ltd. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	EndoZip System	The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-02-10
• Completion: 2023-07-03
• First posted: 2021-02-26
• Last updated: 2025-08-13
• Results posted: 2025-08-13

Locations

1 site across 1 country: Spain