Ultrasound in Muscle Biopsy
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|ClinicalTrials.gov Identifier: NCT01790178|
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : November 15, 2016
Last Update Posted : January 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myopathy Myositis Muscular Dystrophy||Procedure: Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Ultrasound Guided Biopsy
Ultrasound guided biopsy will be used in all patients.
The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.
No Intervention: Non-Ultrasound Guided Group
The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
- Amount of Tissue Obtained [ Time Frame: At time of biopsy ]This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).
- Number of Patients Receiving Diagnosis From Muscle Biopsy [ Time Frame: At time of biopsy ]The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.
- Number of Participants With Adverse Events Related to Muscle Biopsy [ Time Frame: Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy ]Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.
- Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue [ Time Frame: At time of biopsy ]For "core" or "needle" biopsies, the physician passes the needle into the muscle until they feel that adequate tissue samples have been obtained. This outcome measure is the number of passes required in each study arm.
- Number of Participants With Inadequate Biopsy Samples [ Time Frame: At time of pathology review ]The presence of an inadequate sample was determined by the blinded pathologist reading the muscle biopsies. This reflects the sample having enough preserved muscle tissue for histologic analysis. It is separate from the number of participants receiving a diagnosis. A sample may be adequate, but non-diagnostic. Only one biopsy was performed in each patients, so the number of biopsies is the same as the number of participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790178
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Lisa D. Hobson-Webb, MD||Duke University|