Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 8/12/2018 |
| Start Date: | December 12, 2016 |
| End Date: | December 16, 2022 |
| Contact: | Abigail Lowe |
| Email: | ABIGAIL.LOWE@UCDENVER.EDU |
| Phone: | 303-724-6070 |
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.
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.
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
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Mihir Wagh, MD
Phone: 303-724-6070
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