Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome

Thayer Intellectual Property

Status

Terminated

Conditions

Carpal Tunnel Syndrome

Treatments

Device: MANOS CTR™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01450735

THA001

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.