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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450735
Recruitment Status : Terminated (Enrollment did not reach our intended sample size due to availability of CTR with MANOS outside of the study.)
First Posted : October 12, 2011
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
Thayer Intellectual Property, Inc.

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: MANOS CTR™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Intervention Details:
    Device: 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.

Primary Outcome Measures :
  1. Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System. [ Time Frame: 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 Outcome Measures :
  1. Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events. [ Time Frame: Baseline throughout 12 weeks post-operatively ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450735

United States, California
The Hand Treatment Center
Hayward, California, United States, 94545
Neurospine Institute Medical Group
San Francisco, California, United States, 94115
William Bowen, MD Orthopedic Surgery
Willits, California, United States, 95490
Sponsors and Collaborators
Thayer Intellectual Property, Inc.

Responsible Party: Thayer Intellectual Property, Inc. Identifier: NCT01450735     History of Changes
Other Study ID Numbers: THA001
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries