Prospective Multicenter Study With the Endomina® Triangulation Platform

Obesity Clinical Trial

— PRETTi  

Official title:

Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677464
• Other study ID #: ST-2019-001
• Status: Recruiting
• Start date: June 8, 2020
• Est. completion date: March 31, 2026

Study information

• Verified date: December 2022
• Source: Endo Tools Therapeutics S.A.
• Contact: Mrs Leclercq
• Phone: 003271495517
• Email: pretti[@]endotools.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Belgium	Endo Tools Therapeutics S.A.	Gosselies	Wallonie

Sponsors (1)

Lead Sponsor	Collaborator
Endo Tools Therapeutics S.A.

Country where clinical trial is conducted

Belgium, 

Outcome

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