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Trial Title:
22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract
NCT ID:
NCT01726010
Condition:
Subepithelial Tumors of the Upper Gastrointestinal Tract
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
22-G Procore Needle
Arm group label:
22-G Procore Needle
Summary:
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinikum rechts der Isar
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Stefan von Delius, MD
Email:
stefan_ruckert@yahoo.de
Contact backup:
Last name:
Christoph Schlag, MD
Email:
Christoph.Schlag@lrz.tum.de
Investigator:
Last name:
Stefan von Delius, MD
Email:
Principal Investigator
Investigator:
Last name:
Christoph Schlag, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gregor Weirich, MD
Email:
Sub-Investigator
Start date:
September 2012
Completion date:
October 2013
Lead sponsor:
Agency:
Technical University of Munich
Agency class:
Other
Source:
Technical University of Munich
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01726010
