Assessing the safety and efficacy of the Endomina® device for obesity treatment
Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty
This study is testing if the Endomina® device can safely help adults with obesity lose weight over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Endo Tools Therapeutics S.A. Industry-sponsored |
| Locations | 1 site (Gosselies, Wallonie) |
| Trial ID | NCT05677464 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the safety and efficacy of the Endomina® device and tissue apposition accessories (TAPES) in a real-world clinical setting. It is a single-arm, prospective, multi-center, open-label study that will enroll adult patients requiring endoscopic gastroplasty. Participants will be followed for 36 months to gather data on outcomes related to the use of these devices in routine practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who require endoscopic gastroplasty and are selected by a multidisciplinary team.
Not a fit: Patients with contraindications to the procedure, such as impaired hemostasis or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from obesity.
How similar studies have performed: While this approach is being assessed in a larger scale, similar studies have shown promise in evaluating endoscopic devices for obesity treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gosselies, Wallonie
- Endo Tools Therapeutics S.A. — Gosselies, Wallonie, Belgium (Recruiting)
Study contacts
- Study coordinator: Mrs Leclercq
- Email: pretti@endotools.be
- Phone: 003271495517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.