NCT01663493

Brief Summary

This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
3.1 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

August 9, 2012

Last Update Submit

February 11, 2017

Conditions

Pancreas Mass Diagnosis

Outcome Measures

Primary Outcomes (1)

  • number of passes

    1 week

Study Arms (2)

Fine needle aspiration needle

OTHER

standard Beacon FNA needle

Procedure: FNB

fine needle biopsy needle

OTHER

SharkCore fine needle biopsy needle

Procedure: FNB

Interventions

FNBPROCEDURE
Fine needle aspiration needlefine needle biopsy needle

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • pancreas mass

You may not qualify if:

  • coagulopathy
  • mass not approachable by endoscopic ultrasound biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Linda S Lee

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

US(1)