Acoustic Liver Biopsy in Normals and in Patients With Cir... | NCT01208311

Studies
Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound

NCT01208311

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Dec 29, 2016Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Alcoholism
Cirrhosis
Hepatitis c

Interventions

Not provided

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

Dec 2016

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

Dec 2004

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Sep 22, 2010

First Submission Date that Met QC Criteria

Sep 22, 2010

First Posted Date

Sep 23, 2010Estimated

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

Dec 28, 2016

Last Update Posted Date

Dec 29, 2016Estimated

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

The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Detailed Description

Background: Transabdominal ultrasound cannot be used to quantitate fibrosis in patients with cirrhosis due to variability in the abdominal wall thickness and composition. This variability can be eliminated by using endoscopic ultrasound.

Aim: To determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
Patients with Hepatitis C Cirrhosis		Patients with Hepatitis C Cirrhosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Luminosity on ultrasound		Once at the time of the endoscopic ultrasound

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hepatic cirrhosis and hepatitis C and undergoing endoscopy
Alcoholic liver and undergoing endoscopy
Normal liver undergoing endoscopy

Exclusion Criteria:

pregnancy
Children

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Collect endoscopic ultrasound images form normal subjects, alcoholic liver patients and patients with hepatitis C Cirrhosis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Larry S Miller, M.D	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LIJ Medical Center- NSLIJ Health System		New Hyde Park	New York	11040	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8988182	Background	Brown JJ, Naylor MJ, Yagan N. Imaging of hepatic cirrhosis. Radiology. 1997 Jan;202(1):1-16. doi: 10.1148/radiology.202.1.8988182. No abstract available.
9520988	Background	Mergo PJ, Ros PR. Imaging of diffuse liver disease. Radiol Clin North Am. 1998 Mar;36(2):365-75. doi: 10.1016/s0033-8389(05)70028-2.

ID	Term
D000437	Alcoholism
D005355	Fibrosis
D006526	Hepatitis C
D008104	Liver Cirrhosis, Alcoholic

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders