- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03209947
ULnar Nerve ECHographic Observation (ULNECHO) (ULNECHO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
100 elbows from 50 patients will be included, from a population of asymptomatic subjects, in order to measure the frequency of ulnar nerve which surface is >8,3 mm².
The measures will be realized centered on the epicondyle : 2 cm higher, and 2 cm lower with 2 echographs (ESAOTE) and 2 observers. An inter and intra observer study will also be realized to determine the reproducibility and reliability of the measurements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Brest, France, 29609
- CHRU de Brest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient aged 18 -to 80 years or older
- Patient without any current or previous pathology on the ulnar nerve
- Patients would be able to consent
Exclusion Criteria:
- Patient under administrative supervision or legal guardianship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ulnar nerve ultrasound
|
No drug and no placebo were used in this arm.
Patients were followed by Ultrasound approach by measure of ulnar nerve surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation ulnar nerve surface measure of by two doctors
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC17.0085 ULNECHO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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