Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03626194

Enrollment

500

Registered

2018-08-10

Start date

2016-12-12

Completion date

2026-12-16

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Technical and clinical success in endoscopic tissue apposition	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	From baseline to one year	Based on ASGE criteria

Countries

United States

Contacts

Primary ContactAbigail Lowe

ABIGAIL.LOWE@UCDENVER.EDU303-724-6070

Outcome results