Prospective Multicenter Study With the Endomina® Triangulation Platform

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05677464

Acronym

PRETTi

Enrollment

1000

Registered

2023-01-10

Start date

2020-06-08

Completion date

2026-03-31

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Gastroplasty, Endoscopic gastroplasty, endomina

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belgium

Contacts

Primary ContactMrs Leclercq

pretti@endotools.be003271495517

Backup ContactMr Chau

info@endotools.be003271919409

Outcome results