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22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract (PRO-SET)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Technische Universität München.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: November 4, 2012
Last updated: November 8, 2012
Last verified: September 2012
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.

Condition Intervention
Subepithelial Tumors of the Upper Gastrointestinal Tract Device: 22-G Procore Needle

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • diagnostic yield [ Time Frame: 6 months ]
    Number of patients with adequate tissue sample (which allows definitive diagnosis)

Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 22-G Procore Needle Device: 22-G Procore Needle


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01726010

Klinikum rechts der Isar Recruiting
München, Bavaria, Germany, 81675
Contact: Stefan von Delius, MD   
Contact: Christoph Schlag, MD   
Principal Investigator: Stefan von Delius, MD         
Sub-Investigator: Christoph Schlag, MD         
Sub-Investigator: Gregor Weirich, MD         
Sponsors and Collaborators
Technische Universität München
  More Information

Responsible Party: Technische Universität München Identifier: NCT01726010     History of Changes
Other Study ID Numbers: 102012
Study First Received: November 4, 2012
Last Updated: November 8, 2012 processed this record on August 23, 2017