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 range
22 Years – 65 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.