Prospective Multicenter Study With the Endomina® Triangulation Platform (PRETTi)

Endo Tools Therapeutics

Status: Enrolling

Conditions: Obesity

Study type: Observational

Funder types: Industry

Identifiers

NCT05677464

ST-2019-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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