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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

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
NA
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
NA
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
It is not yet known if there will be a plan to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03747510