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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01726010
First received: November 4, 2012
Last updated: November 8, 2012
Last verified: September 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • diagnostic yield [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01726010     History of Changes
Other Study ID Numbers: 102012
Study First Received: November 4, 2012
Last Updated: November 8, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 23, 2014