NCT03584022Active, not recruiting
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 May 2018
- Start date
- 9 Nov 2018
- Primary completion date
- Mar 2027
- Lead sponsor
- Mayo Clinic
- NCT number
- NCT03584022
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 9 Nov 2018 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior musculoskeletal (joint or soft tissue) infection.
- Have previous trauma to the biopsy site.
Other illness
- Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
- Have diabetes mellitus.
- 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.
Other
- Current smoker.
- Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
- Are pregnant or breast-feeding.
- Unwilling to use adequate contraception.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.