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Evaluating Endoscopic Tissue Apposition

This study is looking at how well and how safely doctors can use techniques like endoscopic suturing and clipping to close tissues inside your body during an endoscopy. This is called "endoscopic tissue apposition." The study aims to see if these methods are effective and safe for various procedures, such as closing holes (perforations) or repairing areas after removing abnormal tissue. You might be able to join if you are an adult (18-89 years old) and are having an endoscopy for one of the listed reasons where tissue apposition is needed. The study will track how successful these procedures are and any side effects for up to one year.

Study design
This is an observational study, meaning researchers will watch and record information from 500 patients undergoing these procedures at their institution. It is not a randomized trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track technical and clinical success, as well as any adverse events, from the start of the procedure up to one year later.

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NCT03626194

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Recruiting
Not specifiedAges 18–89Observational
University of Colorado, Denver
~500 participants
Updated 2024-05-21 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Technical and clinical success in endoscopic tissue apposition
Measured over From baseline to one year
+1 more outcome measured

Conditions

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

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Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Abigail Lowe
[email protected]
303-724-6070
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Technical and clinical success in endoscopic tissue appositionFrom 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 EventsFrom baseline to one year

    Based on ASGE criteria