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

NCT ID: NCT01450735

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-11-30

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thayer Intellectual Property, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Hand Treatment Center

Hayward, California, United States

Neurospine Institute Medical Group

San Francisco, California, United States

William Bowen, MD Orthopedic Surgery

Willits, California, United States

Countries

United States

Other Identifiers

THA001

Identifier Type: -

Identifier Source: org_study_id