Recruiting

Endoscopic Sutures

Sponsor:

Weill Medical College of Cornell University

Code:

NCT02166125

Conditions

Endoscopic Suturing Within the Gastrointestinal Tract

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endosuturing

Study Details

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. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Conditions

Endoscopic Suturing Within the Gastrointestinal Tract

Study ID

NCT02166125

Start date

May, 2013

Status verified date

Feb, 2017

Completion date

Aug 26, 2017

Anticipated

Primary completion date

May 26, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Endoscopic suturing

Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract.

Interventions

Endosuturing

Endoscopic suturing

Primary outcome measure

  • Clinical Success [ Time Frame: 6 months to 1 year ]

Central Contacts and Locations

Central contacts

Michel Kahaleh, MD

646-962-4797mik9071@med.cornell.edu

Monica R Gaidhane, MPH

646-962-4796mog2012@med.cornell.edu

Locations

Ochsner Health Center - Kenner

Recruiting

Kenner, Louisiana, United States, 70065

Contacts

Virendra Joshi, MD

504-464-8588vjoshi@ochsner.org

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Michel Kahaleh, MD

646-962-4797mkahaleh@gmail.com

Monica R Gaidhane, MD, MPH

646-962-4796mog2012@med.cornell.edu

Principal Investigator:

Michel Kahaleh, MD

Digestive Health Associates of Texas

Recruiting

Dallas, Texas, United States, 75208

Contacts

Prashant Kedia, MD

214-941-6891prashant.kedia@dhat.com

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • gastric bypass
  • sleeve gastrectomy
  • esophageal stent
  • suturing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-02-20.