PAVmed CarpX Device Clinical Study

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: CarpX Device

• Registration Number: NCT03747510
• Lead Sponsor: PAVmed Inc.

Brief Summary

To study the safety and feasibility of the CarpX device to divide and release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome (CTS).

Detailed Description

This is a prospective, single center, single arm, study of the CarpX device for treatment of carpel tunnel syndrome. Patients will be followed for up to 30 days post procedure.

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Start: 2019-01-05
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient is > 18 years old
• Patient is scheduled to undergo carpal tunnel release surgery
• Patient has failed to respond to conservative treatment of CTS
• CTS confirmed by strong clinical signs and positive Nerve Conduction Velocity (NCV) test
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures Patient is willing and able to complete follow-up requirements

Exclusion Criteria

• Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand that is unrelated to carpal tunnel syndrome.
• Patient with stiff wrist, suspected space occupying lesions or other anatomic abnormalities of the forearm, wrist or hand or other concerns related to patient anatomy such as small wrist and/or thin skin
• Prior invasive treatment of the hand or wrist for disease processes such as De Quervain's syndrome, arthritic wrist etc. on the intended treatment side
• Previous trauma/fracture or other anatomic abnormalities of the forearm, wrist or hand on the intended treatment side
• 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 severe chronic median nerve neuropathy shown by the EMG and NCS that shows denervation of the thenar muscle
• Active local or systemic infection
• Known allergy to any device component
• Known severe allergy to contrast reagent that cannot be managed with premedication
• Any significant medical condition(s) that would place patient at excessive risk for surgery such as: known bleeding disorder including thrombocytopenia (platelet count < 80,000), thrombasthenia, hemophilia or Von Willebrand's disease, unstable cardiac disease, renal failure or uncontrolled diabetes
• Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from fully participating
• Women who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CarpX Device	CarpX Device	Transverse carpal ligament release with CarpX Device

Primary Outcome Measures

Name	Time	Method
Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.	Through 30-day	Freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.

Secondary Outcome Measures

Name	Time	Method
Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.	Through 30-day	Defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.

Trial Locations

Locations (1)

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand