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

January 13, 2013 updated by: Thayer Intellectual Property, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Hayward, California, United States, 94545
        • The Hand Treatment Center
      • San Francisco, California, United States, 94115
        • Neurospine Institute Medical Group
      • Willits, California, United States, 95490
        • William Bowen, MD Orthopedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline throughout 12 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline throughout 12 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thayer Intellectual Property, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (ESTIMATE)

October 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 13, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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