The primary study goal is to evaluate the histological characteristic of Silk Voice to evaluate the potential for Silk Voice to deliver long-term results to patients.
The primary study goal is to evaluate the histological characteristic of Silk Voice at a surrogate implantation site to evaluate the potential for Silk Voice to deliver long-term results to patients. Information obtained from this study will help clinician determine Silk Voice's treatment duration and whether Silk Voice is appropriate for their patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
DeNova Research
Chicago, Illinois, United States
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Tissue samples extracted at 6 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.
Time frame: 6 month
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Tissue samples extracted at 12 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.
Time frame: 12 month
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Tissue samples extracted at 24 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.
Time frame: 24 month
Number of patient and number of reported adverse events reported
Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated.
Time frame: 6 month
Number of patient and number of reported adverse events reported
Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated.
Time frame: 12 month
Number of patient and number of reported adverse events reported
Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated.
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Time frame: 24 month