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

NCT01450735 | Terminated DMC

• 1 other identifier: THA001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.

  Baseline throughout 12 weeks post-operatively

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thayer Intellectual Property, Inc.: lead

Study Sites (3)

The Hand Treatment Center

Hayward, California, 94545, United States

Location

Neurospine Institute Medical Group

San Francisco, California, 94115, United States

Location

William Bowen, MD Orthopedic Surgery

Willits, California, 95490, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 12, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (3)