22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract
Subepithelial Tumors of the Upper Gastrointestinal Tract
Study Type
Study Phase
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: 22-G Procore Needle
Type: Device
Overall Status
The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the upper gastrointestinal tract.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Patient age 18 years and older

2. All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm)

Exclusion Criteria:

1. Unable to obtain informed consent

2. ASA class 4 or 5

3. known pregnancy

4. contraindication endoscopy

5. contraindication for taking biopsies
Klinikum rechts der Isar
München, Bavaria, Germany
Status: Recruiting
Contact: Stefan von Delius, MD - stefan_ruckert@yahoo.de
Start Date
September 2012
Completion Date
October 2013
Technische Universität München
Technische Universität München
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page