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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04327154




Registration number
NCT04327154
Ethics application status
Date submitted
26/03/2020
Date registered
30/03/2020
Date last updated
19/09/2024

Titles & IDs
Public title
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
Scientific 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.
Secondary ID [1] 0 0
PF00004-DC-2002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digital Nerve Injury 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TISSIUM™ Nerve Coaptation Device

Experimental: bacTRL-Spike - * Group 1 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 1 billion colony forming units (cfu) of Bifidobacterium longum (B. longum);
* Group 2 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 3 billion cfu of B. longum;
* Group 3 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 10 billion cfu of B. longum;
* Group 4 (n=3): Single Data and Safety Monitoring Board (DSMB)-defined dose of bacTRL-Spike among subjects 56 years of age and older.
* Group 5 (n=12): DSMB-defined prime and boost doses of bacTRL-Spike delivered with a 28-day intervening interval.

Experimental: Digital nerve repair - 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.


Treatment: Devices: TISSIUM™ Nerve Coaptation Device
Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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;

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
16/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2024
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tissium
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.
Trial website
https://clinicaltrials.gov/study/NCT04327154
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Randipsingh Bindra
Address 0 0
Gold Coast University Hospital
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/NCT04327154