Prospective Multicenter Study With the Endomina® Triangulation Platform

NCT05677464 | Recruiting

• 1 other identifier: ST-2019-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

Obesity; Gastroplasty; Endoscopic gastroplasty; endomina

Outcome Measures

Primary Outcomes (2)

• Safety outcome

  Occurrence of Serious Adverse Device Effects at 12 months.

  12 months

• Technical success

  Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency

  1 day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Tools Therapeutics S.A.: lead

Study Sites (1)

Endo Tools Therapeutics S.A.

Gosselies, Wallonia, 6041, Belgium

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mrs Leclercq

  Endo Tools Therapeutics S.A.

  STUDY DIRECTOR

Central Study Contacts

Mrs Leclercq

CONTACT

003271495517; pretti@endotools.be

Mr Chau

CONTACT

003271919409; info@endotools.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: June 8, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2026
• Last Updated: January 10, 2023

Record last verified: 2022-12

Locations

BE (1)