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

Carpal Tunnel Syndrome Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01450735
• Other study ID #: THA001
• Status: Terminated
• Phase: N/A
• First received: October 6, 2011
• Last updated: January 13, 2013
• Start date: October 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Thayer Intellectual Property, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	The Hand Treatment Center	Hayward	California
United States	Neurospine Institute Medical Group	San Francisco	California
United States	William Bowen, MD Orthopedic Surgery	Willits	California

Sponsors (1)

Lead Sponsor	Collaborator
Thayer Intellectual Property, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.		Baseline throughout 12 weeks post-operatively	No