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

December 23, 2022 updated by: Endo Tools Therapeutics S.A.

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Wallonie
      • Gosselies, Wallonie, Belgium, 6041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients, who require endoscopic gastroplasty (ESG) and who are selected by multidisciplinary team/investigators to be treated with the endomina® device.

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcome
Time Frame: 12 months
Occurrence of Serious Adverse Device Effects at 12 months.
12 months
Technical success
Time Frame: 1 day
Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Tools Therapeutics S.A.

Investigators

  • Study Director: Mrs Leclercq, Endo Tools Therapeutics S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-2019-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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