Overview
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
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.
Eligibility
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