Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Methodist Health System

Status: Completed

Conditions: Endoscopic Suturing; Gastrointestinal Disorders; GI Tract Disorders

Treatments: Procedure: Interventional Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05127408

021.GID.2019.D

Details and patient eligibility

About

The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract for various GI tract disorders. Currently, lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.

Full description

This study is a prospective, observational, medical chart review for at least six standards of care visits up to 1 year after subject consents for study participation. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - April 2019. Those subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic suturing procedures from April 2019 to April 2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic suturing procedure and standard of care follow up visits.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
• Above or equal to 18 years of age

Exclusion criteria

• Any patient who has not undergone endoscopic suturing within the gastrointestinal tract
• Below 18 years of age