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

Primary Purpose

Degenerative Diseases, Nervous System

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PMD-200
SLR
Sponsored by
Medasense Biometrics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Degenerative Diseases, Nervous System

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Galil Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

degenerative lumbar spine disease

Arm Description

patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200

Outcomes

Primary Outcome Measures

discrimination between nonpainful period to painful period
To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test

Secondary Outcome Measures

Correlates with changes in pain levels
To demonstrate that the NoL Index is correlates with changes in pain levels of the subject prior and following SLR.

Full Information

First Posted
December 21, 2017
Last Updated
May 2, 2021
Sponsor
Medasense Biometrics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03389048
Brief Title
Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Protocol compliance and inability to support proper performance
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medasense Biometrics Ltd

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
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Diseases, Nervous System

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
degenerative lumbar spine disease
Arm Type
Experimental
Arm Description
patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200
Intervention Type
Device
Intervention Name(s)
PMD-200
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
SLR
Intervention Description
With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.
Primary Outcome Measure Information:
Title
discrimination between nonpainful period to painful period
Description
To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test
Time Frame
Through study completion, about one year
Secondary Outcome Measure Information:
Title
Correlates with changes in pain levels
Description
To demonstrate that the NoL Index is correlates with changes in pain levels of the subject prior and following SLR.
Time Frame
Through study completion, about one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Soustiel, Prof.
Organizational Affiliation
Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galil Medical Center
City
Nahariya
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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