Recruiting

PRETTiAssessment of Endomina® Triangulation Platform Safety and Efficacy in Endoscopic Gastroplasty

Study Aim

This observational study aims to evaluate the safety of the Endomina® Triangulation Platform in endoscopic gastroplasty by monitoring for serious adverse effects over 12 months, and to assess its technical success by determining if the intended procedure can be completed without premature abortion due to technical reasons or device deficiency.

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 65 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.

Observational

Study Start: June 2020

See protocol details

Summary

Principal SponsorEndo Tools Therapeutics S.A.

Study ContactMrs LeclercqMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 8, 2020

Actual date on which the first participant was enrolled.

This study focuses on evaluating the safety and effectiveness of the Endomina® Triangulation Platform and TAPES devices. These devices are used in a procedure called endoscopic gastroplasty, which is a type of surgery performed inside the stomach without making large incisions. The study involves patients who require this specific procedure. The goal is to gather more information on a larger scale about the safety and efficiency of these devices in real-world use, potentially improving care for those needing this type of surgery. During the study, participants will undergo the endoscopic gastroplasty procedure using the Endomina® and TAPES devices. The study will follow their progress for 36 months after the procedure. The main outcomes being measured are the occurrence of any serious side effects related to the devices within 12 months, and the technical success of the procedure. Technical success is defined by the completion of the intended procedure without any early interruptions due to technical issues or device malfunctions.

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

NCT05677464

Principal SponsorEndo Tools Therapeutics S.A.

Study ContactMrs LeclercqMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

3 inclusion criteria required to participate

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)

6 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Endo Tools Therapeutics S.A.

Gosselies, BelgiumOpen Endo Tools Therapeutics S.A. in Google Maps

Recruiting

One Study Center