A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

This is an interventional basic science trial for Vocal Fold Palsy focused on measuring silk, vocal fold Read More

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.