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NitiNotes' EndoZip System for the Treatment of Obesity

NCT03472196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-02-23

No results posted yet for this study

Summary

This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.

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

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2019-05-08
Completion
2019-05-08

Countries

  • Spain

Study Locations

More Related Trials

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 NCT03472196 on ClinicalTrials.gov