TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial

Digital Nerve Injury Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04327154
• Other study ID #: PF00004-DC-2002
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: September 2023
• Source: Tissium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 15, 2024
• Est. primary completion date: September 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

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;

Related Conditions & MeSH terms

• Digital Nerve Injury

Intervention

Device:
• TISSIUM™ Nerve Coaptation Device
Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Gold Coast University Hospital	Gold Coast	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Tissium

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	through 12-months post-procedure
Secondary	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	at 6 months post-procedure