EUS-FNA With and Without Suction | NCT02072915

Studies
EUS-FNA With and Without Suction

NCT02072915

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Nov 10, 2014Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Solid Pancreatic Mass Lesions

Interventions

Suction

Countries

United States

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Feb 25, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 27, 2014Estimated

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 7, 2014

Last Update Posted Date

Nov 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suction	Experimental	Suction will be applied to patients undergoing EUS-FNA	Procedure: Suction
Without suction	No Intervention	No suction will be applied to patients undergoing EUS-FNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Suction	Procedure		Suction

Measure	Description	Time Frame
Number of passes		once at baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA.

Exclusion Criteria:

Age < 19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR>1.6, Prothrombin Time>18 secs, Thrombocytopenia < 80,000 cells/ml)
- Unable to consent
- Non-English speaking patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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

Name	Affiliation	Role
Jayapal Ramesh, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAB		Birmingham	Alabama	35294	United States

Intervention Browse Module

MeSH Terms

ID	Term
D013396	Suction

Ancestor Terms

ID	Term
D004322	Drainage
D013514	Surgical Procedures, Operative

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Browse Branches

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