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

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ClinicalTrials.gov Identifier: NCT03810326
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yuinvent Innovations Ltd.

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: CTR device (tradename named Xtend) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Actual Study Start Date : January 12, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020


Arm Intervention/treatment
Experimental: Intervention Device: CTR device (tradename named Xtend)
Non invasive active splint




Primary Outcome Measures :
  1. Reduction in pain score [ Time Frame: 10 weeks ]
    Reduction in NRS reported pain score



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03810326


Contacts
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Contact: Oleg Dulcart, PHd +972-(0)524-262544 olegd@tlvmc.gov.il

Locations
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Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Oleg Dulcart    +9720524262544 ext +9720524262544    olegd@tlvmc.gov.il   
Sponsors and Collaborators
Yuinvent Innovations Ltd.

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Responsible Party: Yuinvent Innovations Ltd.
ClinicalTrials.gov Identifier: NCT03810326     History of Changes
Other Study ID Numbers: VY-CTS1-01
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries