22-G-Procore Needle for the Diagnosis of SETs of the Uppe... | NCT01726010

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

NCT01726010

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Nov 14, 2012Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Subepithelial Tumors of the Upper Gastrointestinal Tract

Interventions

22-G Procore Needle

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Nov 4, 2012

First Submission Date that Met QC Criteria

Nov 8, 2012

First Posted Date

Nov 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
22-G Procore Needle	Experimental		Device: 22-G Procore Needle

Name	Type	Description	Arm Group Labels	Other Names
22-G Procore Needle	Device		22-G Procore Needle

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age 18 years and older
All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm)

Exclusion Criteria:

Unable to obtain informed consent
ASA class 4 or 5
known pregnancy
contraindication endoscopy
contraindication for taking biopsies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar	Recruiting	München	Bavaria	81675	Germany