Carpal Tunnel Syndrome
Conditions
Brief 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.
Interventions
DEVICEMANOS 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.
Sponsors
Thayer Intellectual Property, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System. | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events. | Baseline throughout 12 weeks post-operatively |
Countries
United States
Outcome results
None listed