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

This study is currently recruiting participants.
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
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 April 17, 2014