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

NCT04773795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-13

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nitinotes Surgical Ltd.

    lead INDUSTRY

Principal Investigators

  • Ravit Peled · NiTiNotes Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-02-10
Completion
2023-07-03

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04773795 on ClinicalTrials.gov