a histological study evaluating silk voice and crosslinked hyaluronic acid

Conditions: Vocal Fold Palsy; Vocal Cord Paralysis; Vocal Cord Atrophy

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.

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.

Eligibility criteria:
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 exclusion criteria: * a history of allergy or hypersensitivity to injectable hyaluronic acid gel; * a history of allergy or hypersensitivity to silk; * a history of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies * history of allergies of lidocaine * a history of susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders. * currently have a hyaluronic acid device implanted * the presence of any contraindication to the implant procedures, including use of platelet inhibiting agents or other anticoagulant, in a relevant period before study entry (per the treating investigator's judgment); * the presence of any condition, which in the opinion of the investigator, that makes the subject unable to complete the study per protocol; * the presence of known allergies or hypersensitivity reactions to local topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject); * the presence of cancerous or pre-cancerous lesions in the area to be treated; * the presence of moderate or severe abnormal rating for firmness or detection of any abnormal structure at the site of injection, such as a scar or lump; * the current use of immunosuppressive therapy; * who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites * a history of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis or scleroderma; * participation in any interventional clinical research study within 30 days prior to randomization; * subjects not likely to stay in the study for up to 13 months because of other commitments, concomitant conditions, or past history; * subjects anticipated to be unreliable; or subjects who have a concomitant condition that might confuse or confound study treatments or assessments; * subject with skin conditions (discoloration, textured, scarring, etc.) in postauricular region that may complicate study evaluation metrics * subjects that are not considered to be an appropriate candidate at the discretion of the investigator.

Keywords: silk, vocal fold