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

NCT04327154 | Completed

• 1 other identifier: PF00004-DC-2002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Digital Nerve Injury

Keywords

nerve repair; digital nerve repair; digital nerve lesion; peripheral nerve injury; peripheral nerve lesion; peripheral nerve repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Semmes-Weinstein monofilament (SWMF) for nerve functional recovery

  at 6 months post-procedure

Study Arms (1)

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.

Device: TISSIUM™ Nerve Coaptation Device

Interventions

TISSIUM™ Nerve Coaptation Device DEVICE

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

Digital nerve repair

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing a repair of a proper digital nerve of the hand;
• % 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tissium: lead

Study Sites (2)

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Gold Coast University Hospital

Gold Coast, Queensland, 4215, Australia

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Randipsingh Bindra

  Gold Coast University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: December 16, 2022
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-09

Locations

AU (2)