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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03626194
Other study ID # 16-1826
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 12, 2016
Est. completion date December 16, 2026

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact Abigail Lowe
Phone 303-724-6070
Email ABIGAIL.LOWE@UCDENVER.EDU
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 16, 2026
Est. primary completion date December 16, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical and clinical success in endoscopic tissue apposition 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.. From baseline to one year
Primary Adverse Events Based on ASGE criteria From baseline to one year
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