Carpal Tunnel SyndromeNCT03810326
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
A study testing CTR device (tradename named Xtend) in people with Carpal Tunnel Syndrome, run by Yuinvent Innovations Ltd. at 1 site in Israel.
Trial summary
Interventional study to evaluate efficacy and safety of an active splint. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- CTR device (tradename named Xtend)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Jan 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Oleg Dulcart, +9720524262544 ext. +9720524262544, olegd@tlvmc.gov.il
About this study
Interventional study to evaluate efficacy and safety of an active splint.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- CTR device (tradename named Xtend)
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTR device (tradename named Xtend)Device
Non invasive active splint
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: CTR device (tradename named Xtend) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain score
Reduction in NRS reported pain score
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start12 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuinvent Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810326
- Sponsor's protocol ID
- VY-CTS1-01
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03810326
- Acronym / sponsor ID
- VY-CTS1-01
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuinvent Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional study to evaluate efficacy and safety of an active splint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: CTR device (tradename named Xtend) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTR device (tradename named Xtend)Non invasive active splint | Device | Intervention |
Primary outcome
Reduction in pain score
Time frame: 10 weeks
Reduction in NRS reported pain score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTR device (tradename named Xtend) in people with Carpal Tunnel Syndrome, run by Yuinvent Innovations Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oleg Dulcart, PHd (+972-(0)524-262544, olegd@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain score (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.