Back to resultsULnar Nerve ECHographic Observation (ULNECHO) (ULNECHO)
Primary Purpose
Ulnar Neuropathies
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ulnar nerve Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Ulnar Neuropathies focused on measuring Ulnar Neuropathies, Ultrasound
Eligibility Criteria
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
Sites / Locations
- CHRU de Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ulnar nerve ultrasound
Arm Description
Outcomes
Primary Outcome Measures
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
Secondary Outcome Measures
Correlation ulnar nerve surface measure of by two doctors
Full Information
NCT ID
NCT03209947
First Posted
July 4, 2017
Last Updated
April 20, 2018
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03209947
Brief Title
ULnar Nerve ECHographic Observation (ULNECHO)
Acronym
ULNECHO
Official Title
ULnar Nerve ECHographic Observation (ULNECHO)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathies
Keywords
Ulnar Neuropathies, Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ulnar nerve ultrasound
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Ulnar nerve Ultrasound
Intervention Description
No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach by measure of ulnar nerve surface
Primary Outcome Measure Information:
Title
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Correlation ulnar nerve surface measure of by two doctors
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ULnar Nerve ECHographic Observation (ULNECHO)
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