Status:
TERMINATED
Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
Lead Sponsor:
Medasense Biometrics Ltd
Conditions:
Degenerative Diseases, Nervous System
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure
Detailed Description
The proposed study is design to further demonstrates the capability of the Nociception Level, (NoL) Index in identify and discriminate between painful event and non-painful period following pain stimu...
Eligibility Criteria
Inclusion
- Age over 18 and less than 65 (18 \< Age \< 65).
- The subject suffer from unilateral degenerative lumbar spine disease
- The subject suffer from leg pain only in one leg, while no pain in the other leg.
- The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease
- A signed Informed Consent Form (ICF) has been obtain from the subject
Exclusion
- The subject has a bi-lateral degenerative lumbar spine disease
- The subject is pregnant
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03389048
Start Date
March 8 2018
End Date
November 30 2019
Last Update
May 6 2021
Active Locations (1)
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1
Galil Medical Center
Nahariya, Israel