Back to resultsPAVmed CarpX Device Clinical Study
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
CarpX Device
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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
Sites / Locations
- Christchurch Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CarpX Device
Arm Description
Transverse carpal ligament release with CarpX Device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03747510
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PAVmed Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CarpX Device
Arm Type
Experimental
Arm Description
Transverse carpal ligament release with CarpX Device
Intervention Type
Device
Intervention Name(s)
CarpX Device
Intervention Description
Transverse carpal ligament release with CarpX Device
Primary Outcome Measure Information:
Title
Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.
Description
Freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.
Time Frame
Through 30-day
Secondary Outcome Measure Information:
Title
Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.
Description
Defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.
Time Frame
Through 30-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Creagh, MD
Organizational Affiliation
Creagh & Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Learn more about this trial
PAVmed CarpX Device Clinical Study
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