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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01726010

Acronym

PRO-SET

Enrollment

Registered

2012-11-14

Start date

2012-09-30

Completion date

2013-10-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subepithelial Tumors of the Upper Gastrointestinal Tract

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.

Interventions

DEVICE22-G Procore Needle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026