← Back to all trials
Recruiting
NCT05677464
Prospective Multicenter Study With the Endomina® Triangulation Platform
Conditions: Obesity
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Enrollment: 1000
Sponsor: Endo Tools Therapeutics S.A.
Location: Belgium
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
Eligibility Criteria
Inclusion Criteria:Patient must be willing to provide written informed consentAdult 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 failureWoman 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 tractParticipation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint
Source: ClinicalTrials.gov (NCT05677464). StuddyBuddy aggregates publicly available trial information.