Prospective Multicenter Study With the Endomina® Triangulation Platform

Recruiting

• Conditions: Obesity

• Registration Number: NCT05677464
• Lead Sponsor: Endo Tools Therapeutics S.A.

Brief Summary

This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice

Detailed Description

This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.

Study Timeline

• Study Start: 2020-06-08
• Status Verified: 2022-12
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patient must be willing to provide written informed consent
• Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG)
• Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU)

Exclusion Criteria

• Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach)
• Any malformation from mouth to esophagus (including pharynx)
• Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure
• Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure.
• Impending surgery 60 days post intervention of the treated section of the GI tract
• Participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety outcome	12 months	Occurrence of Serious Adverse Device Effects at 12 months.
Technical success	1 day	Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency

Trial Locations

Locations (1)

Endo Tools Therapeutics S.A.; 🇧🇪 Gosselies, Wallonie, Belgium