NCT01726010

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 14, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

November 4, 2012

Last Update Submit

November 8, 2012

Conditions

Subepithelial Tumors of the Upper Gastrointestinal Tract

Outcome Measures

Primary Outcomes (1)

  • diagnostic yield

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

    6 months

Study Arms (1)

22-G Procore Needle

EXPERIMENTAL
Device: 22-G Procore Needle

Interventions

22-G Procore NeedleDEVICE
22-G Procore Needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2012

First Posted

November 14, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

November 14, 2012

Record last verified: 2012-09

Locations

DE(1)