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

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ClinicalTrials.gov Identifier: NCT01726010
Recruitment Status : Unknown
Verified September 2012 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : November 14, 2012
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief 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.

Condition or disease Intervention/treatment Phase
Subepithelial Tumors of the Upper Gastrointestinal Tract Device: 22-G Procore Needle Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : September 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: 22-G Procore Needle Device: 22-G Procore Needle



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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726010


Locations
Germany
Klinikum rechts der Isar Recruiting
München, Bavaria, Germany, 81675
Contact: Stefan von Delius, MD       stefan_ruckert@yahoo.de   
Contact: Christoph Schlag, MD       Christoph.Schlag@lrz.tum.de   
Principal Investigator: Stefan von Delius, MD         
Sub-Investigator: Christoph Schlag, MD         
Sub-Investigator: Gregor Weirich, MD         
Sponsors and Collaborators
Technische Universität München

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01726010     History of Changes
Other Study ID Numbers: 102012
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: September 2012