Endoscopic Suturing (ES) Registry

Completed

Conditions studied: Surgery

In brief

To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable. To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.

Key facts

Study ID

NCT03776188

Run by

American Gastroenterological Association

People needed

204

Starts

2018-10-29

Expected to finish

2021-11-30

Last updated by the study team

2021-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Selected to undergo trans-orifice suturing prior to study enrollment
• Age 18+ years
• Patient ASA classification I, II, III, including emergency cases
• Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment

You may not qualify if…

• Patients who do not meet the clinical criteria for trans-orifice suturing
• Under age 18 years
• ASA classification IV
• Unable to provide informed consent
• Unable to participate in follow-up assessments
• Uncorrectable coagulopathy at the time of endoscopic suturing
• Any terminal disease that limits patient's survival to less than one year

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Borland Grover Clinic — Jacksonville, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Johns Hopkins Medical Institution — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• Northwell Health — Manhasset, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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