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

November 8, 2012 updated by: Technical University of Munich

Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 22-G Procore Needle
Device: 22-G Procore Needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic yield
Time Frame: 6 months
Number of patients with adequate tissue sample (which allows definitive diagnosis)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 102012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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