Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Sutures for Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Conditions
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Endoscopic Suturing, GI Tract Disorders, Gastrointestinal Disorders

Intervention / Treatment
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* Procedure: Interventional Endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Interventional Endoscopy|correct defects of the gastrointestinal tract.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of successful procedures. | 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 | October 2014 to April 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of unsuccessful procedures. | Documentation of follow up adverse events and recurrence of initial GI disorder | October 2014 to April 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sutures, gi