A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Voluma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 12
- 主要终点
- Primary safety endpoint
研究概览
简要总结
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.
详细描述
This will be a post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi- centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Voluma for the correction of midface volume deficit by tissue augmentation in cheek region.
Subjects desiring correction of cheek volume at the participating sites will be asked to participate in the clinical investigation. According to the national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.
If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 6 months with follow-up and assessments either by physical visits to a clinic (Visit 2 and Visit 4) or by phone call (Visit 3).
A total of 4 visits (including screening Visit 0) at the site are planned for each subject.
Standardized facial photography will be taken prior to and after treatment during Visit 1 and during each follow-up visit at the clinic (Visit 2 and 4), for evaluation according to GAIS grading and for the exploratory instrumental evaluation of cheek volume. GAIS will be used for blinded investigator assessment, treating investigator assessment and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
- •Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
- •Has any treatments (thrombolytics, anticoagulants) or disease related to the coagulation system.
- •Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
- •Patients receiving interferon and ribavirin treatment.
- •Features that may interfere with the visual assessment such as recent cosmetic treatment,scarring, abscess, piercing or tattoo.
- •Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
- •Employees of the study site or the sponsor directly involved with the conduct of the investigation.
结局指标
主要结局
Primary safety endpoint
时间窗: Baseline to end of study (6 months)
The primary safety endpoint is to assess the safety of Decoria® Voluma, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.
Primary efficacy endpoint
时间窗: From pre-intervention baseline, to 6 months post-treatment
The primary efficacy endpoint is the blinded evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, which ranges from score 1 (exceptionally improved), 2 (much improved), 3 (improved), 4 (no change) to 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in cheek volume according to the GAIS grading. Each side of the face (left and right) will be assessed independently.
次要结局
- Secondary endpoint(Baseline, 30 days and 180 days post treatment)
- Secondary endpoint(Baseline, 30 days and 180 days post treatment)