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Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT05127408
Collaborator
(none)
58
Enrollment
1
Location
23.3
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Interventional Endoscopy

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
58 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Endoscopic Sutures for Gastrointestinal Tract Disorders: A Prospective Multicenter Registry
Actual Study Start Date :
May 7, 2019
Actual Primary Completion Date :
Apr 14, 2021
Actual Study Completion Date :
Apr 14, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Documentation of unsuccessful procedures. [October 2014 to April 2021]

    Documentation of follow up adverse events and recurrence of initial GI disorder

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Prashant Kedia, MD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05127408
Other Study ID Numbers:
  • 021.GID.2019.D
First Posted:
Nov 19, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Methodist Health System
Sutures
gi
Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Disease

Study Results

No Results Posted as of Mar 8, 2022