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Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure

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ClinicalTrials.gov Identifier: NCT03389048
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Medasense Biometrics Ltd

Brief Summary:
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure

Condition or disease Intervention/treatment Phase
Degenerative Diseases, Nervous System Device: PMD-200 Diagnostic Test: SLR Not Applicable

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 stimulus of Straight Leg Raising (SLR) test in patients with degenerative lumbar spine disease. This feasibility study may provide first indication for a validation method that will be able to evaluate the outcome of a surgical procedure within the degenerative lumbar spine patient. Currently, there is lack of understanding of long-term outcomes after such surgeries.

In this study, the investigators plan to demonstrate that the NoL Index may serve as an indicator to the surgical procedure outcome. It will compare the objective measurement of the NoL to the patient Visual Analogue Scale (VAS) score and disability questionnaire that will characterize the subject pain perception prior and following the surgical procedure.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: degenerative lumbar spine disease
patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200
Device: PMD-200
The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)
Diagnostic Test: SLR
With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.



Primary Outcome Measures :
  1. discrimination between nonpainful period to painful period [ Time Frame: Through study completion, about one year ]
    To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test


Secondary Outcome Measures :
  1. Correlates with changes in pain levels [ Time Frame: Through study completion, about one year ]
    To demonstrate that the NoL Index is correlates with changes in pain levels of the subject prior and following SLR.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • The subject has a bi-lateral degenerative lumbar spine disease
  • The subject is pregnant

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): NCT03389048


Contacts
Contact: Merav Gat, M.Sc. +972-73-7690321 ext 216 merav@medasense.com

Locations
Israel
Galil Medical Center Recruiting
Nahariya, Israel
Contact: Reut Peled    +972-546230889      
Sponsors and Collaborators
Medasense Biometrics Ltd
Investigators
Principal Investigator: Jean Soustiel, Prof. Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

Responsible Party: Medasense Biometrics Ltd
ClinicalTrials.gov Identifier: NCT03389048     History of Changes
Other Study ID Numbers: CLI-16-04
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spinal Diseases
Nervous System Diseases
Neurodegenerative Diseases
Bone Diseases
Musculoskeletal Diseases