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

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

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: CTR device (tradename named Xtend)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Oleg Dulcart; Phone Number: +9720524262544 +9720524262544; Email: olegd@tlvmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: CTR device (tradename named Xtend); Non invasive active splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in pain score	Reduction in NRS reported pain score	10 weeks

Collaborators and Investigators

• Sponsor: Yuinvent Innovations Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: VY-CTS1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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