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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01450735
Other study ID # THA001
Secondary ID
Status Terminated
Phase N/A
First received October 6, 2011
Last updated January 13, 2013
Start date October 2011
Est. completion date November 2012

Study information

Verified date January 2013
Source Thayer Intellectual Property, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
MANOS CTRâ„¢
The MANOS device is a carpal tunnel blade used to release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome.

Locations

Country Name City State
United States The Hand Treatment Center Hayward California
United States Neurospine Institute Medical Group San Francisco California
United States William Bowen, MD Orthopedic Surgery Willits California

Sponsors (1)

Lead Sponsor Collaborator
Thayer Intellectual Property, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Baseline throughout 12 weeks post-operatively No
Secondary Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events. Baseline throughout 12 weeks post-operatively No
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