PAVmed CarpX Device Clinical Study

NCT03747510 | Completed

• 1 other identifier: PAVmed CarpX-01-018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.

  Through 30-day

Study Arms (1)

CarpX Device

EXPERIMENTAL

Transverse carpal ligament release with CarpX Device

Device: CarpX Device

Interventions

CarpX Device DEVICE

Transverse carpal ligament release with CarpX Device

CarpX Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PAVmed Inc.: lead

Study Sites (1)

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Terrence Creagh, MD

  Creagh & Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 20, 2018
• Study Start: January 5, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-02

Locations

NZ (1)