Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Completed

• Conditions: Endoscopic Suturing; GI Tract Disorders; Gastrointestinal Disorders

• Registration Number: NCT05127408
• Lead Sponsor: Methodist Health System

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-05-07
• Primary Completion: 2021-04-14
• Study Completion: 2021-04-14
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documentation of successful procedures.	October 2014 to April 2021	Documentation of technical success (in terms of technical feasibility) Documentation of clinical success rates. Documentation of Safety: Number of subjects with Adverse Events; Type, frequency and intensity of adverse events

Secondary Outcome Measures

Name	Time	Method
Documentation of unsuccessful procedures.	October 2014 to April 2021	Documentation of follow up adverse events and recurrence of initial GI disorder

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States