Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.

1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.

1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.

Recruiting

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Key information

Conditions

Endoscopic Tissue Apposition Bariatric Endoscopy Endoscopic Clipping Endoscopic Sleeve Gastroplasty Endoscopic Suturing Transoral Outlet Reduction

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Abigail Lowe

CONTACT

[email protected]

303-724-6070

Mihir Wagh, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients>18 years of age undergoing endoscopy for any of the following indications:

Indications for Tissue Apposition:

Closure of perforations
Closure of full thickness defects created during endoscopic full thickness resection
Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection
Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)
Stent fixation
Closure of fistulas
Natural Orifice Transluminal Endoscopic Surgery defect closures
Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)
Primary endoscopic sleeve gastroplasty

Exclusion criteria

Patients unable or unwilling to provide consent
Pregnant patients
Coagulation disorders (INR >1.8, platelet <50,000)
GI Bleeding
Hemodynamic instability
Enrollment in another device or drug study that may confound the results

Treatment and study plan

Primary outcomes

Technical and clinical success in endoscopic tissue apposition

Time frame: From baseline to one year

Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed..
Adverse Events

Time frame: From baseline to one year

Based on ASGE criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Lowe

CONTACT

[email protected]

303-724-6070

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2025
Study completion: 2026
First posted: Aug 10, 2018
Registry last updated: May 21, 2024

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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