Clinical trial NCT03747510: PAVmed CarpX Device Clinical Study
Official title: Prospective, Single-Center, Single Arm, Feasibility Study of the PAVmed CarpX Device for the Treatment of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: PAVmed Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.
timeFrame: Through 30-day
Secondary outcomes:
measure: Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.
timeFrame: Through 30-day
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Creagh & Associates
name: Terrence Creagh, MD
role: PRINCIPAL_INVESTIGATOR
References: