- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02514317
Percutaneous Treatment of Carpal Tunnel Syndrome With Scan (ECHOCARPE)
Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.
The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.
The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Caen, France, 14000
- University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient older than 18 years who signed the informed consent.
- Patient with an Carpal Tunnel Syndrome
Exclusion Criteria:
- patient has already undergone surgery of Carpal Tunnel Syndrome
- Patient with contra-indications to anesthesia (heart failure, kidney, liver).
- Pregnant women
- alcoholics in weaning period
- Patient whose consent is altered or unable to get a safety procedure
- Patient with contra-indication to lidocaine
- Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: percutaneous treatment
percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain (visual analogic scale)
Time Frame: change between baseline and day 90 after surgery
|
visual analogic scale
|
change between baseline and day 90 after surgery
|
|
paresthesia
Time Frame: change between baseline and day 90 after surgery
|
change between baseline and day 90 after surgery
|
|
|
muscle strength (dynamometer JAMARD)
Time Frame: change between baseline and day 90 after surgery
|
dynamometer JAMARD
|
change between baseline and day 90 after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Carpal Tunnel Syndrome
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Ultrasonography
Other Study ID Numbers
- 11-058
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.
Clinical Trials on Carpal Tunnel Syndrome
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Stanford UniversityMayo Clinic; National Institute of Arthritis and Musculoskeletal and Skin Diseases... and other collaboratorsCompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
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Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
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Galala UniversityCompletedCarpal Tunnel Syndrome (CTS)Egypt
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Stanford UniversityCompletedCarpal Tunnel Syndrome (CTS)United States
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Fundacin Biomedica Galicia SurCompletedCarpal Tunnel Syndrome (CTS)Spain
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GCS Ramsay Santé pour l'Enseignement et la RechercheCompletedCarpal Tunnel Syndrome (CTS) | Heel Pain SyndromeFrance
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Clinical Trials on Ultrasound
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-
Cairo UniversityUnknown
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Ohio State University Comprehensive Cancer CenterWithdrawn
-
Oregon Health and Science UniversityRecruiting
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Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States
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Odense University HospitalEnrolling by invitationThoracic Ultrasound | Fibrosing Interstitial Lung DiseasesDenmark
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Bursa Yüksek İhtisas Education and Research HospitalCompletedShoulder Impingement Syndrome | Shoulder PainTurkey
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John PelleritoGeneral ElectricActive, not recruiting