Prospective Multicenter Study With the Endomina® Triangulation Platform

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-08

Study Completion Date

2026-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes