A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

Sofregen Medical

Status: Completed

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

Treatments: Device: Silk Voice

Study type: Interventional

Funder types: Industry

Identifiers

NCT04315415

SOF-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

6 month explant

Other group

Description:

Silk Voice and control material are implanted. The implanted material is explanted at 6 months.

Treatment:

Device: Silk Voice

12 month explant

Other group

Description:

Silk Voice and control material are implanted. The implanted material is explanted at 12 months.

Treatment:

Device: Silk Voice

24 month explant

Other group

Description:

Silk Voice and control material are implanted. The implanted material is explanted at 24 months.

Treatment:

Device: Silk Voice