Clinical Study for the Effectiveness of Use of an Injectable Medical Device GANA X® in the Treatment of Buttocks Volume Depression
Phase: NA
Conditions: Buttocks Volume Loss
Sponsor: GCS Co., Ltd

GCS Co., Ltd. 
GANA X® 
CIP #21E0805 
Final version 3.0 
Date: 07/04/2022 
Page 1/5 
 
SUMMARY OF THE CLINICAL INVESTIGATION PLAN # 21E0805 
 
ANSM registration #: 
2021-A02728-33 
Clinical investigation plan #: 
21E0805 
Title of the clinical investigation: 
CLINICAL STUDY FOR THE EFFECTIVENESS OF USE OF AN 
INJECTABLE MEDICAL DEVICE GANA X® IN THE TREATMENT 
OF BUTTOCKS VOLUME DEPRESSION 
Sponsor: 
GCS Co., Ltd. 
1008 Ho, Sunil Technopia Bldg, 
555 Dunchon-daero 
Jungwon-gu, Seongnam-si, Gyeonggi-do 
KOREA 
Development phase 
Post market study 
Interventional 
Device used according to Instruction For Use (IFU) 
Objectives: 
The primary objective is to evaluate the effectiveness of Gana X® in 
improving buttocks volume 6 months after treatment. 
 
The secondary objectives of the study are: 
- 
to evaluate the effectiveness of Gana X® in improving 
buttocks volume 11/2, 9, 12, 18 and 24 months after 
treatment. 
- 
to evaluate the effectiveness of Gana X® on the global 
aesthetic improvement of buttocks 11/2, 6, 9, 12, 18, 24 
months after treatment as rated by the evaluator. 
- 
to evaluate the effectiveness of Gana X® on the global 
aesthetic improvement of buttocks 11/2, 6, 9 12, 18, 24 
months after treatment as rated by the subjects. 
- 
To evaluate the subject satisfaction with Gana X® 11/2, 6, 9, 
12, 18 and 24 months after treatment. 
- 
To evaluate the injector satisfaction with Gana X® after initial 
and touch-up injection if applicable.  
- 
To evaluate the safety of Gana X®. 
Design: 
The study will be:  
• 
In open, 
• 
Single center. 
Planned Sample Size: 
55 subjects included.  
Number of investigational study 
sites: 
1 site (France). 
Inclusion criteria: 
1. Healthy Subject. 
2. Sex: male or female. 
3. Age: between 18 and 65 years. 
4. Subject with mild to moderate buttock volume depression and/or 
seeking buttocks volume augmentation based on investigator 
evaluation. 
5. Subject wiling to abstain from other body contouring procedures 
during the whole study period. 
6. Subject psychologically able to understand the study related 
information and to give a written informed consent. 
7. Subject having given freely and expressly his/her informed 
consent. 
8. Subject willing to have photographs taken. 

GCS Co., Ltd. 
GANA X® 
CIP #21E0805 
Final version 3.0 
Date: 07/04/2022 
Page 2/5 
 
9. Subject affiliated to a health social security system. 
10. Female of childbearing potential should use a contraceptive 
regimen recognized as effective since at least 12 weeks before 
screening visit and during the whole study period.  
Exclusion criteria: 
1. Pregnant or nursing woman or having given birth within the last 
year or planning a pregnancy during the study. 
2. Excessive subcutaneous fat in the area to be treated. 
3. Excessive skin laxity on the area to be treated. 
4. Severe buttocks ptosis. 
5. Subject who had been deprived of their freedom by 
administrative or legal decision or who is under guardianship. 
6. Subject in a social or sanitary establishment 
7. Subject participation to another research on human beings or 
who is in an exclusion period of one. 
8. Subject having already received 4500 euros indemnities for 
participation in research involving human beings in the 12 
previous months or exceeding these 4500 euros with his 
participation in the present study. 
9. Subject suspected to be non-compliant according to the 
investigator’s judgment. 
10. Subject suffering from a severe or progressive disease or any 
other pathology that may interfere with the evaluation of the 
study results. 
11. Subject with known history of or suffering from autoimmune 
disease and/or immune deficiency. 
12. Subject with a history of cellulitis, streptococcal disease, such as 
acute rheumatic fever or recurrent sore throats and in case of 
acute rheumatic fever with heart complications. 
13. Subject 
suffering 
from 
inflammatory 
and/or 
infectious 
cutaneous disorders in or near the studied zones (e.g. acne, 
chronic eczema, atopic dermatitis…).  
14. Subject with an abscess, unhealed wound, or a cancerous or 
precancerous lesion on the studied zone. 
15. Subject prone to develop inflammatory skin conditions or 
having tendency to bleeding disorders. 
16. Subject with a tendency to develop keloids or hypertrophic 
scarring. 
17. Subject with significant scarring, open wounds, lesions or 
tattoos in or near the area to be treated. 
18. Subject having history of allergy or anaphylactic shock 
including hypersensitivity to Poly-l-lactic acid, to lidocaine or to 
one of the components of the tested devices or antiseptic 
solution. 
19. Subject having received a dose of COVID-19 vaccine within the 
14 days prior to injection visits or planning to receive a dose in 
the 14 days following injections.  
20. Subject having received treatment on or near the buttocks (laser, 
dermabrasion, surgery, radiofrequency, cryolipolysis, buttocks 
electrostimulation, endermologie, liposuction, other energy-
based treatment, surgery…) within the 12 months prior to 
screening visit. 
21. Subject having received injection with a resorbable filling 
product in or near the buttocks within the 12 months prior to 
screening visit. 
22. Subject having received at any time the following treatments in 
the area to be treated: 
• 
Buttocks implants; 

GCS Co., Ltd. 
GANA X® 
CIP #21E0805 
Final version 3.0 
Date: 07/04/2022 
Page 3/5 
 
• 
Buttocks fillers (e.g., silicone, semi-permanent or permanent 
fillers or autologous fat injections); 
• 
Injections for the treatment of cellulitis. 
23. Subject having started or changed her oral contraceptive or any 
other hormonal treatment during 12 weeks prior to screening 
visit. 
24. Subject using medication such as aspirin, nonsteroidal anti-
inflammatory 
drugs 
(NSAID) 
(ibuprofen, 
naproxen, 
…), 
antiplatelet agents, anticoagulants or other substances known to 
prolong bleeding time within 1 week prior to injection visits. 
25. Subject undergoing a topical treatment on the test area or a 
systemic treatment: 
• 
Antihistamines during the 2 weeks prior to injections visits 
(D0 and touch-up visit). 
• 
Immunosuppressors and/or corticoids during the 4 weeks 
prior to injections visits (D0 and touch-up visit). 
• 
Retinoids during the 6 months prior to injections visits (D0 
and touch-up visit). 
26. Intensive exposure to sunlight or UV-rays within the month before 
injection visits and one month after. 
27. Subject planning to loss or gain weight for the duration of the 
study. 
28. Subject planning to change her/his life habits during the study. 
Investigational device: 
Name / code 
Classification 
Ingredient 
 
Galenic form 
Administration route 
 
Gana X®  
Class III medical device 
Poly-L-Lactic Acid (630mg), Sodium Carboxymethyl Cellulose, 
Mannitol. 
Sterile freeze-dried preparation (powder) 
Injection in the deep dermis and subcutaneous layer. 
Endpoints: 
Primary effectiveness endpoint:  
Mean change in buttocks volume from baseline to 6 months after 
treatment using fringe projection system. 
 
Secondary effectiveness endpoints: 
- 
Mean change in buttocks volume from baseline to 11/2, 9, 12, 
18 and 24 months after treatment using fringe projection 
system. 
- 
GAIS responder rates 11/2, 6, 9, 12, 18 and 24 months after 
treatment as assessed by an independent live evaluator. A 
responder is defined as a subject having “Improved”, “Much 
improved” or “Very much improved” score according to 
GAIS. 
- 
GAIS responder rates 11/2, 6, 9, 12, 18 and 24 months after 
treatment as assessed by the subjects.  
- 
Proportion of satisfied subjects 11/2, 6, 9, 12, 18 and 24 
months after treatment using a questionnaire. 
- 
Injector’s satisfaction regarding injection quality after initial 
and touch-up injection using a questionnaire. 
Secondary safety endpoints: 
Investigational device safety will be assessed by collection of 
Injection Site Reactions (ISRs) and Adverse Events (AEs) throughout 

GCS Co., Ltd. 
GANA X® 
CIP #21E0805 
Final version 3.0 
Date: 07/04/2022 
Page 4/5 
 
the study by the investigator. Subjects will record ISRs and AEs in 
their subject diaries. 
Study Procedures: 
A screening visit will allow to inform and preselect the subjects. 
 
On D0, fringe projection acquisitions and photographs will be done 
before injection. Eligible subjects will receive a first injection of the 
investigational device. Immediately after injection, injector’s 
treatment satisfaction will be collected. Investigator evaluator will 
collect AEs and ISRs immediately after injection.   
 
A month and a half after initial injection (M11/2), GAIS scoring, fringe 
projection acquisitions and photographs will be done before touch-up 
injection (if applicable). A touch-up injection will be made if 
necessary, according to injector and subject opinion. Investigator 
evaluator will collect AEs and ISRs before and after touch-up if 
applicable. Subject’s treatment satisfaction and injector’s treatment 
satisfaction (if applicable) will be collected. 
 
Six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four 
(M24) months after initial injection, effectiveness scoring (GAIS 
scale), fringe projection acquisitions and photographs will be done. 
Subject’s treatment satisfaction will be collected. Investigator 
evaluator will collect AEs and ISRs 
Statistical methods: 
For the primary evaluation criterion: 
The primary endpoint is the mean change in buttocks volume from 
baseline to 6 months after treatment using fringe projection system. 
Descriptive statistics for quantitative data (N, mean, standard 
deviation, minimum and maximum) will be presented at D0 before 
injection and M6. 
Inferential analysis: 
 
A Wilcoxon signed rank test, or a paired t test will be applied to 
evaluate the change from baseline (D0 before injection) to M6. 
The normality assumption will be tested using a Shapiro Wilk test 
(α=0.01). The bilateral approach will be used. 
For the secondary evaluation criteria: 
 
All the variables will be described using adapted statistics according 
to their type (quantitative data or qualitative data). 
For quantitative data a Wilcoxon or paired t test will be applied to 
assess the change from baseline. 
 
The bilateral approach will be used with a significance level of 0.05. 
Foreseen study duration: 
Clinical investigation beginning: Q1 2022  
Clinical investigation end: Q3 2024 
Inclusion duration: Maximum 6 months 
Clinical investigation global duration: 30 months  
Duration by subject: 24 months + screening period 
 
 
 

GCS Co., Ltd. 
GANA X® 
CIP #21E0805 
Final version 3.0 
Date: 07/04/2022 
Page 5/5 
 
FLOW-CHART 
 
Procedure 
Visit 1 
Screening 
Visit 2 
Day 0 
Visit 3 
M11/2 
Visit 4 
M6 
Visit 5 
M9 
Visit 6 
M12 
Visit 7 
M18 
Visit 8 
M24 
Days 
D-X  
D0 
D40 ± 2 
D160 ± 
4 
D270 
±4 
D365 ± 
7 
D540 ± 
14 
D730 ± 
14 
Informed consent form signature 

 
 
 
 
 
 
 
Medical examination 

 
 
 
 
 
 
 
Medical history and previous 
and concomitant treatments 
collection 

 
 
 
 
 
 
 
Checking of the inclusion and 
exclusion criteria 

 
 
 
 
 
 
 
Pregnancy test 

b 
b 
 
 
 
 
 
Confirmation of eligibility 

b
 
 
 
 
 
 
Photographs 

b 
b 
 

 
 
 
Fringe projection acquisitions (2 
areas) 

b
b





Injection + anaesthesia (if 
necessary) 


Touch up 
 
 
 
 
 
GAIS live assessment by an 
independent evaluator 


b 
 

 
 
 
GAIS assessment by the 
subjects 


b





Subjective evaluation 
questionnaire for subjects 


b





ISR live assessment by an 
independent evaluator 

a
b+a





ISR assessment by the subjects 

Completed each day during 4 
weeks after injection at home 
by the subject. 
 
 
 
 
Subjective evaluation 
questionnaire for injector  

a
a 
 
 
 
 
 
AE and concomitant treatments 
and procedures collection 
 

 
 




Study end 
 







Keys: b: Before injection; a: After injection