22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract (PRO-SET)
November 8, 2012 updated by: Technical University of Munich
Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
München, Bavaria, Germany, 81675
- Recruiting
- Klinikum rechts der Isar
-
Contact:
- Stefan von Delius, MD
- Email: stefan_ruckert@yahoo.de
-
Contact:
- Christoph Schlag, MD
- Email: Christoph.Schlag@lrz.tum.de
-
Sub-Investigator:
- Christoph Schlag, MD
-
Sub-Investigator:
- Gregor Weirich, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient age 18 years and older
- All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm)
Exclusion Criteria:
- Unable to obtain informed consent
- ASA class 4 or 5
- known pregnancy
- contraindication endoscopy
- contraindication for taking biopsies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 22-G Procore Needle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
diagnostic yield
Time Frame: 6 months
|
Number of patients with adequate tissue sample (which allows definitive diagnosis)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
November 4, 2012
First Submitted That Met QC Criteria
November 8, 2012
First Posted (Estimate)
November 14, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2012
Last Update Submitted That Met QC Criteria
November 8, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 102012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.