PAVmed CarpX Device Clinical Study

Prospective, Single-Center, Single Arm, Feasibility Study of the PAVmed CarpX Device for the Treatment of Carpal Tunnel Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: CarpX Device

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CarpX Device; Transverse carpal ligament release with CarpX Device	Device: CarpX Device; Transverse carpal ligament release with CarpX Device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PAVmed Inc.
• Investigators: Principal Investigator: Terrence Creagh, MD, Creagh & Associates

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: PAVmed CarpX-01-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No