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

• Sponsor: Technische Universität München (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01726010
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subepithelial Tumors of the Upper Gastrointestinal Tract	Device: 22-G Procore Needle	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Oct 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. diagnostic yield [6 months]

   Number of patients with adequate tissue sample (which allows definitive diagnosis)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum rechts der Isar	München	Bavaria	Germany	81675

Sponsors and Collaborators

• Technische Universität München

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technische Universität München
• ClinicalTrials.gov Identifier: NCT01726010
• Other Study ID Numbers: 102012
• First Posted: Nov 14, 2012
• Last Update Posted: Nov 14, 2012
• Last Verified: Sep 1, 2012

Study Results

No Results Posted as of Nov 14, 2012