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TISSIUM™ Nerve Coaptation Device First-in-Human Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04327154
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to collect and report in human preliminary safety and device performance data of the TISSIUM™ Nerve Coaptation Device for the repair of digital nerve discontinuities where gap closure can be achieved by flexion of the extremity. The study will be conducted at up to 4 centres and will enroll up to 12 subjects.

Condition or disease Intervention/treatment Phase
Digital Nerve Injury Device: TISSIUM™ Nerve Coaptation Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : February 2022

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.

Primary Outcome Measures :
  1. Repair success [ Time Frame: at time of procedure ]
    Ability to implant the device and quality of the nerve repair will be assessed by investigators during the nerve repair procedure using a visual scoring scale.

  2. cumulative incidence of complications (CIC) [ Time Frame: at 3-month post-procedure ]

    CIC includes the occurrence of any of the following complications:

    • Allergy reaction to the constituent polymer of the investigational device;
    • Infection (redness, increasing swelling, pain, lymphangitis or positive wound cultures, etc);
    • Excessive inflammation as determined by the Investigator;
    • Implant extrusion;
    • Neuroma formation (Elliot score);
    • Wound related problems (dehiscence, pain, skin irritation, keloid, scar hypertrophy, etc.);
    • Serious Adverse Device Effect (SADEs).

Secondary Outcome Measures :
  1. Cumulative incidence of SADEs [ Time Frame: at 12 months post-procedure ]
    Cumulative incidence of procedure related or device related serious adverse events

  2. Improved sensory recovery [ Time Frame: at 3, 6 and 12 months ]
    Sensory recovery measured by Moving 2PD and Semmes-Weinstein monofilament test

  3. Questionnaire [ Time Frame: at 2 weeks, 1, 3, 6 and 12 months ]
    Patient reported outcome measures (PROMs) as per the I-HAND v2.0 scale

  4. Neuroma formation [ Time Frame: at 12 months post-procedure ]
    Incidence of Neuroma formation assessed by the Elliot score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient undergoing a primary repair of a digital nerve (multiple digital nerve injury cases may be recruited);
  • 100% transection injury to the nerve under test;
  • 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;
  • Subject willing and able to provide a signed Patient Informed Consent Form;
  • Subject willing and able to follow the study instructions and likely to complete all required study procedures and visits.

Exclusion Criteria:

  • Any patient with a known allergy to the constituent polymer of the investigational device;
  • Any patient with a known diagnosis of peripheral neuropathy;
  • Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;
  • Any patient taking neuromodulator medication;
  • Any patient with a life expectancy less than 1 year;
  • Any patient with a history of neuropathic pain;
  • Any patient with a history of injury to the nerve being studied;
  • Any patient missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
  • Any patient unwilling or unable to follow postoperative instructions;
  • Any patient with concomitant intake of systemic immunosuppressive medications, steroids (>20mg of prednisone /day or equivalent) and chemotherapy;
  • Any patient with a prior radiation therapy to the operating field;
  • Pregnancy detected by a blood or urine positive pregnancy test or planned pregnancy during the study period or breast-feeding women;
  • Any patient with a history of chronic ischemic conditions of the extremity;
  • Any patient with a diagnosis of type 1 Diabetes Mellitus;
  • Any patient with a diagnosis of uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);
  • Any patient currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
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Responsible Party: Tissium Identifier: NCT04327154    
Other Study ID Numbers: PF00004-DC-2002
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tissium:
nerve repair
digital nerve repair
digital nerve lesion
peripheral nerve injury
peripheral nerve lesion
peripheral nerve repair