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

This study has been terminated.
(Enrollment did not reach our intended sample size due to availability of CTR with MANOS outside of the study.)
Sponsor:
Information provided by (Responsible Party):
Thayer Intellectual Property, Inc.
ClinicalTrials.gov Identifier:
NCT01450735
First received: October 6, 2011
Last updated: January 13, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Carpal Tunnel Syndrome
 Device: MANOS CTR™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thayer Intellectual Property, Inc.:

Primary Outcome Measures:
  • Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System. [ Time Frame: Baseline throughout 12 weeks post-operatively ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.
    Other Name: MANOS CTR™
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450735

Locations
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.
  More Information

No publications provided

Responsible Party: Thayer Intellectual Property, Inc.
ClinicalTrials.gov Identifier: NCT01450735     History of Changes
Other Study ID Numbers: THA001
Study First Received: October 6, 2011
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013