Carpal Tunnel SyndromeNCT03747510
PAVmed CarpX Device Clinical Study
A study testing CarpX Device in people with Carpal Tunnel Syndrome, run by PAVmed Inc. at 1 site in New Zealand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- CarpX Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 5 Jan 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- CarpX Device
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarpX DeviceDevice
Transverse carpal ligament release with CarpX Device
| Study group | Role | What they receive |
|---|---|---|
| CarpX Device | Experimental | Transverse carpal ligament release with CarpX Device Receives: Device: CarpX Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.
Measured: Through 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start5 Jan 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAVmed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terrence Creagh, MD, Principal investigator, Creagh & Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747510
- Sponsor's protocol ID
- PAVmed CarpX-01-018
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2018
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Center, Single Arm, Feasibility Study of the PAVmed CarpX Device for the Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03747510
- Acronym / sponsor ID
- PAVmed CarpX-01-018
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PAVmed Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CarpX Device | Experimental | Device: CarpX DeviceTransverse carpal ligament release with CarpX Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarpX DeviceTransverse carpal ligament release with CarpX Device | Device | CarpX Device |
Primary outcome
Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.
Time frame: Through 30-day
Freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity.
1 secondary outcome
Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament.
Time frame: Through 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence Creagh, MD principal investigator
Creagh & Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CarpX Device in people with Carpal Tunnel Syndrome, run by PAVmed Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity. (time frame: Through 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.