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

Not Applicable

Active, not recruiting

• Conditions: Digital Nerve Injury
• Interventions: Device: TISSIUM™ Nerve Coaptation Device

• Registration Number: NCT04327154
• Lead Sponsor: Tissium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Study Start: 2022-12-16
• Status Verified: 2023-09
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-09-18
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital nerve repair	TISSIUM™ Nerve Coaptation Device	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of complications (CIC) related to the investigational device	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)

Secondary Outcome Measures

Name	Time	Method
Semmes-Weinstein monofilament (SWMF) for nerve functional recovery	at 6 months post-procedure	Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery

Trial Locations

Locations (2)

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Gold Coast University Hospital; 🇦🇺 Gold Coast, Queensland, Australia