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

Sponsor
Nitinotes Surgical Ltd.
Study ID
NCT04773795
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • EndoZip System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Aug 2025
Primary completion
Feb 10, 2023
Completion
Jul 3, 2023

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 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.

Primary Outcome Measure

Change in Body Total Body Weight Loss (kg) From Baseline to12 Months [ Time Frame: 12 month ]

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