The study aims to confirm the safety and effectiveness of FILLGEL devices
The primary objective is to evaluate the effectiveness of the FILLGEL range used on different treated zones one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by the independent investigator. The secondary objectives of the study are to collect data for the FILLGEL range on: * the effectiveness of the range used on different treated zones six months (M6) and twelve months (M12) . * the safety using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the investigator. * subject's satisfaction and subject's opinion on aesthetic improvement on the different treated zones. * the injector's satisfaction on the injection quality using subjective evaluation questionnaire.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
68
Injection of device by investigators according to the Instruction For Use (IFU)
Kylane Laboratoires
Plan-les-Ouates, Switzerland
Performance
Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the Global Aesthetic Improvement Scale (GAIS) (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 50%.
Time frame: 1 month
Performance - GAIS Investigator
Proportion of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%.
Time frame: 6 months, 12 months
Patients Safety
Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication.
Time frame: Immediatly after injection (D0), 1 month, 6 months, 12 months
Subject Satisfaction - GAIS Subject
Proportion of responders (subjects with a GAIS="improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%.
Time frame: 1, 6, 12 months
Injector Satisfaction
Distribution of each item of the questionnaire answered by the injectors (injector's satisfaction on the injection quality using subjective evaluation questionnaire). The scale is "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied" or "Very satisfied" The percentage of satisfied injectors includes participants that reported being "satisfied" and "very satisfied"
Time frame: After injection
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