Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

NCT05127408 | Completed

• 1 other identifier: 021.GID.2019.D
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Suturing; GI Tract Disorders; Gastrointestinal Disorders

Keywords

Sutures; gi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Documentation of unsuccessful procedures.

  October 2014 to April 2021

Interventions

Interventional Endoscopy PROCEDURE

correct defects of the gastrointestinal tract.

Also known as: Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) (or Endo Stitch™ , the SILS™ Stitch)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract at Methodist Health System in Dallas.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Prashant Kedia, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: May 7, 2019
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

US (1)