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Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CTR device (tradename named Xtend)
Sponsored by
Yuinvent Innovations Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female patients, above 40 years of age.
  • Able to understand and sign informed consent
  • Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
  • Numbness and tingling in the median nerve distribution
  • Nocturnal Numbness
  • Weakness and/or atrophy of the thenar musculature
  • Demonstrate positive Phalen's Test of the affected extremity
  • Demonstrate positive Tinel's Test of the affected extremity
  • Sensory impairment defined as a loss of 2-point discrimination
  • Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome

Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome

  • History of surgical carpal tunnel release
  • Pregnancy
  • Diabetes not controlled by medication
  • Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy
  • Thoracic outlet syndrome
  • Compromised skin integrity
  • Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Sites / Locations

  • Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Reduction in pain score
Reduction in NRS reported pain score

Secondary Outcome Measures

Full Information

First Posted
January 17, 2019
Last Updated
January 17, 2019
Sponsor
Yuinvent Innovations Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03810326
Brief Title
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Official Title
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuinvent Innovations Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Interventional study to evaluate efficacy and safety of an active splint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CTR device (tradename named Xtend)
Intervention Description
Non invasive active splint
Primary Outcome Measure Information:
Title
Reduction in pain score
Description
Reduction in NRS reported pain score
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female patients, above 40 years of age. Able to understand and sign informed consent Pain associated with mild to moderate carpal tunnel syndrome in a single wrist Numbness and tingling in the median nerve distribution Nocturnal Numbness Weakness and/or atrophy of the thenar musculature Demonstrate positive Phalen's Test of the affected extremity Demonstrate positive Tinel's Test of the affected extremity Sensory impairment defined as a loss of 2-point discrimination Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome History of surgical carpal tunnel release Pregnancy Diabetes not controlled by medication Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy Thoracic outlet syndrome Compromised skin integrity Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oleg Dulcart, PHd
Phone
+972-(0)524-262544
Email
olegd@tlvmc.gov.il
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oleg Dulcart
Phone
+9720524262544
Ext
+9720524262544
Email
olegd@tlvmc.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

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