Status:
COMPLETED
A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
Lead Sponsor:
Sofregen Medical, Inc.
Conditions:
Vocal Fold Palsy
Vocal Cord Paralysis
Eligibility:
All Genders
22-65 years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04315415
Start Date
January 15 2020
End Date
April 18 2022
Last Update
April 20 2022
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611