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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Digital Nerve Injury
• Intervention / Treatment: Device: TISSIUM™ Nerve Coaptation Device

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sr. Manager, Clinical Affairs; Phone Number: +1 603-630-2241; Email: ntrinward@tissium.com

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
    • Gold Coast, Queensland, Australia, 4215
      • Gold Coast University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: TISSIUM™ Nerve Coaptation Device; Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tissium
• Investigators: Principal Investigator: Randipsingh Bindra, Gold Coast University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: peripheral nerve injury; nerve repair; digital nerve lesion; peripheral nerve lesion; digital nerve repair; peripheral nerve repair
• Other Study ID Numbers: PF00004-DC-2002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No