N/A
N=40
Ultrasound in Muscle Biopsy
Myopathy · Myositis · Muscular Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT01790178 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Amount of Tissue Obtained — 0.29; 0.28 grams
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Tissue Obtained |
0.29; 0.28 | — |
| PRIMARY Number of Patients Receiving Diagnosis From Muscle Biopsy |
7; 12 | — |
| SECONDARY Number of Participants With Adverse Events Related to Muscle Biopsy |
0; 0 | — |
| SECONDARY Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue |
2.57; 2.5 | — |
| SECONDARY Number of Participants With Inadequate Biopsy Samples |
1; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01790178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.