Vocal Cord Atrophy, Vocal Cord Paralysis, Vocal Fold Palsy
Conditions
Keywords
silk, vocal fold
Brief summary
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.
Detailed description
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.
Interventions
DEVICESilk Voice
Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
Sponsors
Sofregen Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Each subject enrolled will receive implantation of both Silk Voice and control material.
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* To be eligible for enrollment, the Subject must meet the following: * males or non-pregnant, non-breastfeeding females 21 to 65 years old who are willing to comply with the requirements of the study, including sequential photography, periodic check-ins and retrieval of implanted materials; * women of childbearing potential using an acceptable form of birth control during the study period and willingness to take a urine pregnancy test at baseline and at the biopsy date; * sign the Informed Consent form and the Authorization for Use and Release HIPAA form prior to any study-related procedures being performed. * read and understand English
Exclusion criteria
* Patients will not enroll in the study if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation. | 6 month | Tissue samples extracted at 6 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient and number of reported adverse events reported | 6 month | Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated. |
Countries
United States
Outcome results
None listed