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

Not Applicable

• Conditions: Subepithelial Tumors of the Upper Gastrointestinal Tract
• Interventions: Device: 22-G Procore Needle

• Registration Number: NCT01726010
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-11-04
• Study First Submitted QC: 2012-11-08
• Last Update Submitted: 2012-11-08
• Study First Posted: 2012-11-14
• Last Update Posted: 2012-11-14
• Primary Completion: 2013-08
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
22-G Procore Needle	22-G Procore Needle	-

Primary Outcome Measures

Name	Time	Method
diagnostic yield	6 months	Number of patients with adequate tissue sample (which allows definitive diagnosis)

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 München, Bavaria, Germany