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OpenTrials
Completed

NCT Number: NCT05127408

Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

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.

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Key information

Conditions

Endoscopic Suturing Digestive System Diseases GI Tract Disorders Gastrointestinal Diseases Gastrointestinal Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interventional Endoscopy

Procedure

correct defects of the gastrointestinal tract.

Other names: Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) (or Endo Stitch™ , the SILS™ Stitch)

Primary outcomes

  1. Documentation of successful procedures.

    Time frame: 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 outcomes

  1. Documentation of unsuccessful procedures.

    Time frame: October 2014 to April 2021

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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Endoscopic Sutures for Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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