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ULnar Nerve ECHographic Observation (ULNECHO) (ULNECHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209947
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease Intervention/treatment Phase
Ulnar Neuropathies Diagnostic Test: Ulnar nerve Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ULnar Nerve ECHographic Observation (ULNECHO)
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ulnar nerve ultrasound Diagnostic Test: 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




Primary Outcome Measures :
  1. Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Correlation ulnar nerve surface measure of by two doctors [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03209947


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03209947    
Other Study ID Numbers: 29BRC17.0085 ULNECHO
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Ulnar Neuropathies
Ultrasound
Additional relevant MeSH terms:
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Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases