Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

NCT03584022 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 17-008763
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.

Conditions

Peripheral Neuropathy; Vasculitic Neuropathy (Disorder); Amyloidosis; Hereditary Neuropathy; Sarcoid Neuropathy; Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Outcome Measures

Primary Outcomes (1)

• Safety as determined by number of participants with post-surgical reactions

  Post-surgical reactions will include evaluations of the following: 1. Percussion tenderness at site of proximal stump or repair site; 2. Skin redness at the site of biopsy (length and width measured with calipers); 3. Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4. 4. Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.

  up to 5 years post surgery

Secondary Outcomes (6)

• Neuropathic pain as measured by SNAP

  3 months & 12 months

• Neuropathic pain as measured by visual analogue pain scale

  weekly, monthly for first 3 months, then 12 months and yearly for 4 years

• Neuropathic pain as measured by visual analogue pain assessment questionnaire

  weekly, monthly for first 3 months, then 12 months and yearly for 4 years

• Neuroma formation

  3 months & 12 months

• Sensory nerve regeneration as measured by SNAP

  3 months & 12 months

Study Arms (2)

Biopsy + Nerve Repair

EXPERIMENTAL

Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.

Device: Biopsy + Nerve Repair

Biopsy Only

SHAM COMPARATOR

Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.

Procedure: Biopsy Only

Interventions

Biopsy + Nerve Repair DEVICE

During the standard sural nerve biopsy procedure, a single-use, biodegradable implant designed to repair damaged peripheral nerves will be used to repair the nerve. The MCNS1 is a hollow nerve tube made of poly(caprolactone-fumarate) (PCLF), to connect severed nerve ends and promote the growth of regenerating axons.

Biopsy + Nerve Repair

Biopsy Only PROCEDURE

Standard sural nerve biopsy only, without nerve repair.

Biopsy Only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between the ages of 18-75 years
• Have clinical indications for whole sural nerve biopsy
• Have a sural nerve SNAP with amplitude \> or = 2 microvolt (μV)
• Are able to comply with protocol requirements
• Can provide written informed consent
• Willingness to complete study procedures

You may not qualify if:

• Current smoker.
• History of prior musculoskeletal (joint or soft tissue) infection.
• Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
• Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
• Have diabetes mellitus.
• Have previous trauma to the biopsy site.
• Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
• Are pregnant or breast-feeding.
• Unwilling to use adequate contraception.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Amyloidosis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anthony J Windebank, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: Patients planned for diagnostic sural nerve biopsy will be screened. Nerve conduction study of the sural nerve is part of standard of care for patients who are screened for the study. If the amplitude of sensory nerve action potential (SNAP) is equal to or greater than 2 μV and the patient meets the other inclusive criteria, the patient will be recruited to enter the study. Ultrasonography of the sural nerve will be conducted. If the diameter of the sural nerve is greater than 2.75mm, the patient will be assigned to the control group. If sural nerve diameter is equal to or smaller than 2.75mm, the patient will be randomized to either the control or study group. A study team member (clinical coordinator) will draw a number from an envelope that holds equal amount of odd and even numbers. If the number drawn is an odd number, the patient will be assigned to the control group. If the number drawn is an even number, the patient will be assigned to the intervention group.

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: July 12, 2018
• Study Start: November 9, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)