Digital Nerve InjuryNCT04327154
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
A study testing TISSIUM™ Nerve Coaptation Device in people with Digital Nerve Injury, run by Tissium at 2 sites in Australia.
Trial summary
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- TISSIUM™ Nerve Coaptation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesAustralia
- Study dates
- 16 Dec 2022to 10 Sep 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing a repair of a proper digital nerve of the hand;
- 100% transection injury to the nerve under repair;
- Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
- Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
- Patient willing and able to provide a signed Patient Informed Consent Form;
- Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.
Who cannot join
- Patient has a known allergy to the constituent polymer of the investigational device;
- Patient has a documented diagnosis of peripheral neuropathy;
- Patient has a history of neuropathic pain;
- Patient has a history of injury to the nerve being studied;
- Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
- Patient is pregnant or nursing
- Any patient with a diagnosis of type 1 Diabetes Mellitus;
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Gold Coast University Hospital
Gold Coast, Queensland, 4215
About this study
Official title: A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.
- Conditions
- Digital Nerve Injury
- Being tested
- TISSIUM™ Nerve Coaptation Device
- Keywords
- nerve repair, digital nerve repair, digital nerve lesion, peripheral nerve injury, peripheral nerve lesion, peripheral nerve repair
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TISSIUM™ Nerve Coaptation DeviceDevice
Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.
| Study group | Role | What they receive |
|---|---|---|
| Digital nerve repair | Experimental | There is no comparator for this study. All patients are in the treatment allocated group for digital nerve repair with the TISSIUM™ Nerve Coaptation Device. Receives: Device: TISSIUM™ Nerve Coaptation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of complications (CIC) related to the investigational device
CIC includes the occurrence of any of the following complications:
- Infection
- Chronic pain (defined as pain lasting more than 3 months) not otherwise specified
- Excessive inflammation as determined by the investigator
- Device extrusion
- Symptomatic neuroma formation
- Impaired wound healing (examples are dehiscence, pain, skin irritation, keloid, scar hypertrophy)
- Allergic reaction to the constituent polymer of the investigational device
- Serious Adverse Device Effect (SADEs)
Measured: through 12-months post-procedure
Secondary outcomes (1)
Semmes-Weinstein monofilament (SWMF) for nerve functional recovery
Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery
Measured: at 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start16 Dec 2022
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Nerve InjuryStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tissium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randipsingh Bindra, Principal investigator, Gold Coast University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327154
- Sponsor's protocol ID
- PF00004-DC-2002
- Status last verified
- Sep 2023
- First submitted
- 26 Mar 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.
- ClinicalTrials.gov ID
- NCT04327154
- Acronym / sponsor ID
- PF00004-DC-2002
- Conditions
- Digital Nerve Injury
- Keywords
- nerve repair, digital nerve repair, digital nerve lesion, peripheral nerve injury, peripheral nerve lesion, peripheral nerve repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TissiumIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 30 Mar 2020 (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.
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital nerve repair | Experimental | Device: TISSIUM™ Nerve Coaptation DeviceThere is no comparator for this study. All patients are in the treatment allocated group for digital nerve repair with the TISSIUM™ Nerve Coaptation Device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient undergoing a repair of a proper digital nerve of the hand;
- 100% transection injury to the nerve under repair;
- Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
- Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
- Patient willing and able to provide a signed Patient Informed Consent Form;
Key exclusion criteria (7 listed)
- Patient has a known allergy to the constituent polymer of the investigational device;
- Patient has a documented diagnosis of peripheral neuropathy;
- Patient has a history of neuropathic pain;
- Patient has a history of injury to the nerve being studied;
- Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
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 |
|---|---|---|
| TISSIUM™ Nerve Coaptation DevicePlacement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation. | Device | Digital nerve repair |
Primary outcome
Cumulative incidence of complications (CIC) related to the investigational device
Time frame: through 12-months post-procedure
CIC includes the occurrence of any of the following complications: * Infection * Chronic pain (defined as pain lasting more than 3 months) not otherwise specified * Excessive inflammation as determined by the investigator * Device extrusion * Symptomatic neuroma formation * Impaired wound healing (examples are dehiscence, pain, skin irritation, keloid, scar hypertrophy) * Allergic reaction to the constituent polymer of the investigational device * Serious Adverse Device Effect (SADEs)
1 secondary outcome
Semmes-Weinstein monofilament (SWMF) for nerve functional recovery
Time frame: at 6 months post-procedure
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 19 Sep 2024.
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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.
Randipsingh Bindra principal investigator
Gold Coast University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TISSIUM™ Nerve Coaptation Device in people with Digital Nerve Injury, run by Tissium at 2 sites in Australia.
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 6 inclusion and 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
Cumulative incidence of complications (CIC) related to the investigational device (time frame: through 12-months post-procedure). 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 19 Sep 2024.