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

Tracking Information
First Received Date ^ICMJE	October 6, 2011
Last Updated Date	January 13, 2013
Start Date ^ICMJE	October 2011
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 22, 2012)	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
Original Primary Outcome Measures ^ICMJE (submitted: October 7, 2011)	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
Change History	Complete list of historical versions of study NCT01450735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 7, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Carpal Tunnel Syndrome
Intervention ^ICMJE	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™
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	100
Completion Date	November 2012
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01450735
Other Study ID Numbers ^ICMJE	THA001
Has Data Monitoring Committee	Yes
Responsible Party	Thayer Intellectual Property, Inc.
Study Sponsor ^ICMJE	Thayer Intellectual Property, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Thayer Intellectual Property, Inc.
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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