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Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626194
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.


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

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : December 16, 2025
Estimated Study Completion Date : December 16, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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..

  2. Adverse Events [ Time Frame: From baseline to one year ]
    Based on ASGE criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A prospective database/registry of patients undergoing endoscopic tissue apposition will be formed. Women and minorities will be included as they are frequently found to have indications for which endoscopic tissue apposition may be indicated.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626194


Contacts
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Contact: Abigail Lowe 303-724-6070 ABIGAIL.LOWE@UCDENVER.EDU

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Abigail Lowe    303-724-6070    ABIGAIL.LOWE@UCDENVER.EDU   
Principal Investigator: Mihir Wagh, MD         
Sponsors and Collaborators
University of Colorado, Denver
More Information
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Additional Information:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03626194    
Other Study ID Numbers: 16-1826
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No