A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid (NCT04315415) | Clinical Trial Compass
CompletedNot Applicable
A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
United States14 participantsStarted 2020-01-15
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conditi…
What they're measuring
1
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Timeframe: 6 month
2
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Timeframe: 12 month
3
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.