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

Technical University of Munich

Status: Unknown

Conditions: Subepithelial Tumors of the Upper Gastrointestinal Tract

Treatments: Device: 22-G Procore Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01726010

102012

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

22-G Procore Needle

Experimental group

Treatment:

Device: 22-G Procore Needle