22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract

Subepithelial Tumors of the Upper Gastrointestinal Tract Clinical Trial

— PRO-SET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726010
• Other study ID #: 102012
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2012
• Last updated: November 8, 2012
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2012
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Subepithelial Tumors of the Upper Gastrointestinal Tract

Intervention

Device:
• 22-G Procore Needle

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield	Number of patients with adequate tissue sample (which allows definitive diagnosis)	6 months	No