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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726010
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01726010     History of Changes
Other Study ID Numbers: 102012
First Submitted: November 4, 2012
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
Last Verified: September 2012