A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

Completed · Not applicable

Conditions studied: Vocal Fold Palsy, Vocal Cord Paralysis, Vocal Cord Atrophy

In brief

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.

Key facts

Study ID

NCT04315415

Run by

Sofregen Medical, Inc.

People needed

14

Starts

2020-01-15

Expected to finish

2022-04-18

Last updated by the study team

2022-04-20

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• DeNova Research — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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