NCT03810326

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 17, 2019

Last Update Submit

January 17, 2019

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Reduction in pain score

    Reduction in NRS reported pain score

    10 weeks

Study Arms (1)

Intervention

EXPERIMENTAL
Device: CTR device (tradename named Xtend)

Interventions

CTR device (tradename named Xtend)DEVICE

Non invasive active splint

Intervention

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Central Study Contacts

Oleg Dulcart, PHd

CONTACT

+972-(0)524-262544olegd@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

January 12, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)