A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma (NCT06565988) | Clinical Trial Compass
CompletedNot Applicable
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma
Sweden111 participantsStarted 2024-09-02
Plain-language summary
A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region.
Who can participate
Age range
18 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
. Adults ≥18 years, males and females.
. Able and willing to give written informed consent for participation in the investigation.
. Treating investigator considers the subject's cheeks amenable to an improvement of at least 1 grade on the GAIS. At least one side of face should either have a potential to enhance cheek volume or have moderate to severe cheek volume deficit. The grades do not have to be the same on both sides.
. Ability to follow study instructions and likely to complete all required visits.
Exclusion criteria
. Pregnant or lactating females.
. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
. Any corrective procedures performed or planned in the midface region (e.g., silicone implants, permanent fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, dental implants) that may confound the evaluation of safety and performance of the IMD.
. Any other intradermal injection, such as semi-permanent fillers or botulinum toxin (no complications are allowed), received in the same injection area within 12 months of the Treatment visit (Visit 1) that may confound the evaluation of safety and performance of the IMD.
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
Primary efficacy endpoint
Timeframe: From pre-intervention baseline, to 6 months post-treatment