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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03747510




Registration number
NCT03747510
Ethics application status
Date submitted
8/11/2018
Date registered
20/11/2018
Date last updated
1/05/2020

Titles & IDs
Public title
PAVmed CarpX Device Clinical Study
Scientific title
Prospective, Single-Center, Single Arm, Feasibility Study of the PAVmed CarpX Device for the Treatment of Carpal Tunnel Syndrome
Secondary ID [1] 0 0
PAVmed CarpX-01-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Syndrome 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CarpX Device

Experimental: CarpX Device - Transverse carpal ligament release with CarpX Device


Treatment: Devices: CarpX Device
Transverse carpal ligament release with CarpX Device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.
Timepoint [1] 0 0
Through 30-day
Secondary outcome [1] 0 0
Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.
Timepoint [1] 0 0
Through 30-day

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PAVmed Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT03747510
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terrence Creagh, MD
Address 0 0
Creagh & Associates
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03747510