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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01790178
Other study ID # Pro00041999
Secondary ID
Status Completed
Phase N/A
First received February 11, 2013
Last updated January 19, 2016
Start date February 2013
Est. completion date October 2015

Study information

Verified date January 2016
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.

Exclusion Criteria:

- Age under 18 years.

- Inability to provide consent for participation.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound
The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of Tissue Obtained by Ultrasound Guided Muscle Biopsies This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass). 10 months No
Primary Diagnostic Yield of Ultrasound Guided Muscle Biopsies The rate of achieving a final diagnosis in ultrasound guided muscle biopsies vs. unguided muscle biopsies will be examined. 10 months No
Secondary Improving the Safety of Core/Needle Muscle Biopsies Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies. 10 months Yes
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