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

NCT ID: NCT04327154

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2024-09-10

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TISSIUM™ Nerve Coaptation Device

Intervention Type: DEVICE

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

Interventions

TISSIUM™ Nerve Coaptation Device

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

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tissium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randipsingh Bindra

Role: PRINCIPAL_INVESTIGATOR

Gold Coast University Hospital

Locations

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Countries

Australia

Other Identifiers

PF00004-DC-2002

Identifier Type: -

Identifier Source: org_study_id