A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma
- Conditions
- Midface Volume Deficit
- Registration Number
- NCT06565988
- Lead Sponsor
- Bohus Biotech AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Adults =18 years, males and females.<br><br> 2. Able and willing to give written informed consent for participation in the<br> investigation.<br><br> 3. Treating investigator considers the subject's cheeks amenable to an improvement of<br> at least 1 grade on the GAIS. At least one side of face should either have a<br> potential to enhance cheek volume or have moderate to severe cheek volume deficit.<br> The grades do not have to be the same on both sides.<br><br> 4. Ability to follow study instructions and likely to complete all required visits.<br><br>Exclusion Criteria:<br><br> 1. Pregnant or lactating females.<br><br> 2. Any previous hypersensitivity reaction to any constituent of the Investigational<br> medical device (IMD) or to local anaesthetic products.<br><br> 3. Any corrective procedures performed or planned in the midface region (e.g., silicone<br> implants, permanent fillers, absorbable and non-absorbable sutures, laser therapy,<br> dermabrasion, dental implants) that may confound the evaluation of safety and<br> performance of the IMD.<br><br> 4. Any other intradermal injection, such as semi-permanent fillers or botulinum toxin<br> (no complications are allowed), received in the same injection area within 12 months<br> of the Treatment visit (Visit 1) that may confound the evaluation of safety and<br> performance of the IMD.<br><br> 5. Has an ongoing episode/relapse, recently diagnosed or newly started medication of an<br> autoimmune disease, as judged by the investigator.<br><br> 6. Has any chronic or acute skin disease or inflammation (such as pimples, rashes or<br> hives) within or close to the treatment area.<br><br> 7. Has any treatments (thrombolytics, anticoagulants) or disease related to the<br> coagulation system.<br><br> 8. Subjects that have taken any type of vaccine within two weeks prior injection with<br> the IMD.<br><br> 9. Patients receiving interferon and ribavirin treatment.<br><br> 10. Features that may interfere with the visual assessment such as recent cosmetic<br> treatment,scarring, abscess, piercing or tattoo.<br><br> 11. Participation in a clinical investigation that may affect the safety or performance<br> of this investigation, as judged by the Principal Investigator, or authorized<br> designee.<br><br> 12. Employees of the study site or the sponsor directly involved with the conduct of the<br> investigation.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint;Primary safety endpoint
- Secondary Outcome Measures
Name Time Method Secondary endpoint;Secondary endpoint;Secondary endpoint;Secondary endpoint;Secondary endpoint