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This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.
Full description
This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft.
Addendum 1 (MATCH) establishes a comparative arm to collect data on nerve injuries repaired with nerve autografts and nerve tube conduits at select RANGER® participating sites.
Addendum 2 (Sensation-NOW) establishes a focused arm to collect data on autologous breast reconstructive procedures where neurotization was completed. Post-mastectomy autologous breast reconstruction procedures without neurotization will serve as an internal control group to allow for comparisons.
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Inclusion and exclusion criteria
Primary Study Criteria (RANGER Avance):
Inclusion Criteria:
Exclusion Criteria:
• Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up.
Addendum 1 (MATCH) Criteria:
Inclusion Criteria:
Exclusion Criteria:
Addendum 2 (Sensation-NOW) Criteria:
Inclusion Criteria:
Female ≥ 18 years old
Undergo post mastectomy autologous breast reconstruction with one type of autologous flap (no stacked reconstructions or use of implant with autologous flap)
Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest
Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction:
Able to provide informed consent and are willing to comply with post-operative care procedures and assessments
Exclusion Criteria:
Additional Eligibility criteria to Modules
Module 1: Native Skin Reconstructions with and without neurotization.
Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region.
Sensory assessments must be completed on ≥ 8 Zones of Native Skin.
5,000 participants in 4 patient groups
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Central trial contact
Stacy Arnold
Data sourced from clinicaltrials.gov
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