Carpal Tunnel SyndromeNCT01450735
Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome
A study testing MANOS CTR™ in people with Carpal Tunnel Syndrome, run by Thayer Intellectual Property, Inc. at 3 sites in United States.
Trial summary
The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- MANOS CTR™
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to Nov 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is scheduled to undergo carpal tunnel release surgery.
- Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
- Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
- Patient is a male or non-pregnant, non-lactating female.
- Patient is 18-75 years of age, inclusive.
- Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
- Patient must voluntarily provide written, informed consent.
Who cannot join
- Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand.
- Patient has a medical condition that precludes the use of anesthetic required for surgery.
- Patient has an ipsilateral injury or other conditions affecting hand function.
- Patient has acute CTS resulting from an injury (e.g., fracture).
- Patient has had previous CTR surgery on the affected hand.
- Patient has psychiatric history, head injury or any other condition which, in the Investigator's opinion, would prevent patient from complying with post-operative hand therapy or follow-up visits.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Hand Treatment Center
Hayward, California, 94545
Neurospine Institute Medical Group
San Francisco, California, 94115
William Bowen, MD Orthopedic Surgery
Willits, California, 95490
About this study
The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- MANOS CTR™
- 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.
MANOS CTR™Device
The MANOS device is a carpal tunnel blade used to release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System.
Clinical outcome data that will be evaluated:
- Carpal Tunnel Syndrome Questionnaire (CTSQ)
- Scar sensitivity
- Hand sensation
- Grip and pinch strength
- Hand dexterity
Measured: Baseline throughout 12 weeks post-operatively
Secondary outcomes (1)
Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.
Measured: Baseline throughout 12 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Enrollment did not reach our intended sample size due to availability of CTR with MANOS outside of the study.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thayer Intellectual Property, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450735
- Sponsor's protocol ID
- THA001
- Status last verified
- Jan 2013
- First submitted
- 6 Oct 2011
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT01450735
- Acronym / sponsor ID
- THA001
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment did not reach our intended sample size due to availability of CTR with MANOS outside of the study.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thayer Intellectual Property, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Oct 2011 (estimated)
- 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.
The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is scheduled to undergo carpal tunnel release surgery.
- Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
- Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
- Patient is a male or non-pregnant, non-lactating female.
- Patient is 18-75 years of age, inclusive.
Key exclusion criteria (6 listed)
- Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand.
- Patient has a medical condition that precludes the use of anesthetic required for surgery.
- Patient has an ipsilateral injury or other conditions affecting hand function.
- Patient has acute CTS resulting from an injury (e.g., fracture).
- Patient has had previous CTR surgery on the affected hand.
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 |
|---|---|---|
| MANOS CTR™The MANOS device is a carpal tunnel blade used to release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome. | Device | – |
Primary outcome
Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System.
Time frame: Baseline throughout 12 weeks post-operatively
Clinical outcome data that will be evaluated: * Carpal Tunnel Syndrome Questionnaire (CTSQ) * Scar sensitivity * Hand sensation * Grip and pinch strength * Hand dexterity
1 secondary outcome
Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.
Time frame: Baseline throughout 12 weeks post-operatively
Results and safety
The study was stopped early (reason given: Enrollment did not reach our intended sample size due to availability of CTR with MANOS outside of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MANOS CTR™ in people with Carpal Tunnel Syndrome, run by Thayer Intellectual Property, Inc. at 3 sites in United States.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was stopped early (reason given: Enrollment did not reach our intended sample size due to availability of CTR with MANOS outside of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System. (time frame: Baseline throughout 12 weeks post-operatively). 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 15 Jan 2013.