Expired Study
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Lubbock, Texas 79430


Purpose:

This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia. The purpose of this study is to investigate if it is possible to use ultrasound to make a diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is that there will be no statistical difference between the proposed experimental test (Ultrasound) and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary dyskinesia.


Criteria:

Inclusion Criteria: 1. All subjects will have a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of < 3 mm, and no gallstones present. 2. Written informed consent document. 3. Males and Females age > 18 years Exclusion Criteria: 1. Subjects without a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of > 3 mm, and/or gallstones present. 2. Pregnant or breastfeeding women 3. Subjects who do not consent to take part in the study.


Study is Available At:


Original ID:

TT Biliary Dyskinesia


NCT ID:

NCT00737295


Secondary ID:


Study Acronym:


Brief Title:

Ultrasound for Diagnosis of Biliary Dyskinesia


Official Title:

Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Texas Tech University Health Sciences Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

PI left institution, study interest wained-s


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Thomas Warren, MD
Principal Investigator
Texas Tech University Health Sciences Center

Study Dates

Start Date:May 2008
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:June 2010
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 15, 2010
First Received Date:August 14, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Does ultrasound test detect contraction of gallbladder following injection of a hormone cholecystokinin (CCK), and is the degree contraction as accurate as the accepted clinical standard (the HIDA scan) for diagnosis of biliary dyskinesia.
Time Frame:After HIDA scan performed
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:CCK Injection and Ultrasound
Description:All subjects, whether they participate in this study or not, will undergo the HIDA scan as this is the accepted standard of care for diagnosing biliary dyskinesia. If a given subject agrees to participate in this study, he/she will be asked to undergo the following study procedures: If a pregnancy test has not already been done, a urine pregnancy test will be done for women of childbearing potential. An intravenous line (IV) will be inserted (if not already in place), and a standard dose of CC
Arm Name:US

Study Arms

Study Arm Type:Experimental
Arm Name:US
Description:There will be no experimental or control group, rather each individual will act as his/her own control.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Texas Tech University Health Sciences Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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