Buttocks Volume Loss
Conditions
Brief summary
The purpose of this study is to assess the effectiveness and safety of Gana X, a Poly L-lactic acid filler for the aesthetic treatment of buttocks.
Detailed description
A screening visit will allow to inform and preselect the participants. On D0, baseline scoring, fringe projection acquisitions and photographs will be done before injection. Eligible participants will receive a first injection of the product. Immediately after injection, injector's treatment satisfaction will be collected. Investigator evaluator will collect Adverse Events (AEs) and Injection Site Reactions (ISRs) immediately after injection. A month and a half after initial injection (M1 and a half), clinical scoring, fringe projection acquisitions and photographs will be done before touch-up (if applicable). Participant's treatment satisfaction and injector's treatment satisfaction (if applicable) will be collected. A touch-up injection will be made if necessary, according to injector and participant opinion. Investigator evaluator will collect AEs and ISRs before and after touch-up if applicable. Six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four (M24) months after initial injection, clinical scoring, fringe projection acquisitions and photographs will be done. Participant's treatment satisfaction will be collected. Investigator evaluator will collect AEs and ISRs.
Interventions
DEVICEGana X
Injection in the deep dermis and subcutaneous layer of the buttocks on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
Sponsors
Eurofins Dermscan Pharmascan
GCS Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and investigators assessors will know which filler was used.
Intervention model description
All participants will receive the same medical device (Gana X)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject with mild to moderate buttock volume depression and/or seeking buttocks volume augmentation based on investigator evaluation. * Subject wiling to abstain from other body contouring procedures during the whole study period. * Subject psychologically able to understand the study related information and to give a written informed consent. * Subject having given freely and expressly his/her informed consent. * Subject willing to have photographs taken. * Subject affiliated to a health social security system. * 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
* Pregnant or nursing woman or having given birth within the last year or planning a pregnancy during the study. * Excessive subcutaneous fat in the area to be treated. * Excessive skin laxity on the area to be treated. * Severe buttocks ptosis. * Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. * Subject in a social or sanitary establishment * Subject participation to another research on human beings or who is in an exclusion period of one. * 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. * Subject suspected to be non-compliant according to the investigator's judgment. * Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. * Subject with known history of or suffering from autoimmune disease and/or immune deficiency. * 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. * Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. acne, chronic eczema, atopic dermatitis…). * Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone. * Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders. * Subject with a tendency to develop keloids or hypertrophic scarring. * Subject with significant scarring, open wounds, lesions or tattoos in or near the area to be treated. * 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. * 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. * 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. * Subject having received injection with a resorbable filling product in or near the buttocks within the 12 months prior to screening visit. * Subject having received at any time the following treatments in the area to be treated: * Buttocks implants; * Buttocks fillers (e.g., silicone, semi-permanent or permanent fillers or autologous fat injections); * Injections for the treatment of cellulitis. * Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit. * 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. * 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). * Intensive exposure to sunlight or UV-rays within the month before injection visits and one month after. * Subject planning to loss or gain weight for the duration of the study. * Subject planning to change her/his life habits during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Buttocks Volume 6 Months After Treatment | Baseline and Month 6 | This will be assessed using 3D acquisitions of the buttocks analysed on a computer software to evaluate the decrease of the buttocks hollow. To observe an improvement, an increase of the mean change from baseline value was expected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injector Satisfaction | After initial injection (Day 0) | The investigator who will inject the product will complete a questionnaire for each participant. |
| Change From Baseline in Buttocks Volume | Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24 | This will be assessed using 3D acquisitions of the buttocks analysed on a computer software to evaluate the decrease of the buttocks hollow. To observe an improvement, an increase of the mean change from baseline value was expected. |
| Percentage of Satisfied Participants | Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24 | Percentage of participants with positive answers to an internal questionnaire |
| Collection of Injection Site Reactions | Day 0, Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24] | Injection site reactions are usual signs reported after injection and consist on the evaluation of the following signs : Redness / Erythema, Pain / Tenderness, Induration / Firmness, Swelling / Edema, Lumps / Bumps, Bruising, Itching, Coloration, Pigmentation / Discoloration. Data presented are a percentage of subjects presenting at least one ISR of any severity evaluated by the investigator |
| Collection of Adverse Events | Day 0 to Month 24 | Number of Adverse Events (AEs) Number of Adverse Device Effects (ADEs) Percentage of subjects with at least one AE Percentage of subject with at least one ADE |
| Global Aesthetic Improvement Scale (GAIS) Responder Rate | Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24 | Percentage of participants with an improvement on GAIS. A responder is defined as a subject having Improved, Much improved or Very much improved score according to GAIS. |
Countries
France
Participant flow
Recruitment details
The clinical investigation was initiated on 2 May 2022 (first subject first visit). Subjects were recruited from one investigational center, in France. The last subject was screened on 7 November 2022 and the recruitment period lasted 189 days.
Pre-assignment details
126 subjects were screened to randomize 50 subjects
Participants by arm
| Arm | Count |
|---|---|
| Gana X Participants received Gana X in both buttocks | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Gana X | — |
|---|---|---|
| Age, Continuous | 35.06 years STANDARD_DEVIATION 10.49 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 50 participants | — |
| Sex: Female, Male Female | 49 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 31 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
Change From Baseline in Buttocks Volume 6 Months After Treatment
This will be assessed using 3D acquisitions of the buttocks analysed on a computer software to evaluate the decrease of the buttocks hollow. To observe an improvement, an increase of the mean change from baseline value was expected.
Time frame: Baseline and Month 6
Population: Intent To Treat population - any subject included in the study with at least a post-basal value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gana X | Change From Baseline in Buttocks Volume 6 Months After Treatment | 22.21 cm^3 | Standard Deviation 11.65 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Buttocks Volume
This will be assessed using 3D acquisitions of the buttocks analysed on a computer software to evaluate the decrease of the buttocks hollow. To observe an improvement, an increase of the mean change from baseline value was expected.
Time frame: Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included in the study with at least a post-basal value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gana X | Change From Baseline in Buttocks Volume | Change from baseline (D0 visit) to M11/2 visit | 11.99 cm^3 | Standard Deviation 7.73 |
| Gana X | Change From Baseline in Buttocks Volume | Change from baseline (D0 visit) to M9 visit | 21.70 cm^3 | Standard Deviation 12.14 |
| Gana X | Change From Baseline in Buttocks Volume | Change from baseline (D0 visit) to M12 visit | 22.29 cm^3 | Standard Deviation 13.38 |
| Gana X | Change From Baseline in Buttocks Volume | Change from baseline (D0 visit) to M18 visit | 16.95 cm^3 | Standard Deviation 11.6 |
| Gana X | Change From Baseline in Buttocks Volume | Change from baseline (D0 visit) to M24 visit | 10.96 cm^3 | Standard Deviation 10.21 |
Secondary
Collection of Adverse Events
Number of Adverse Events (AEs) Number of Adverse Device Effects (ADEs) Percentage of subjects with at least one AE Percentage of subject with at least one ADE
Time frame: Day 0 to Month 24
Population: Safety population - any subject having used the investigational device
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana X | Collection of Adverse Events | Subjects with at least one AE: | With | 39 Participants |
| Gana X | Collection of Adverse Events | Subjects with at least one AE: | Without | 11 Participants |
| Gana X | Collection of Adverse Events | Subjects with at least one SAE: | With | 1 Participants |
| Gana X | Collection of Adverse Events | Subjects with at least one SAE: | Without | 49 Participants |
| Gana X | Collection of Adverse Events | subjects with at least one ADE: | With | 28 Participants |
| Gana X | Collection of Adverse Events | subjects with at least one ADE: | Without | 22 Participants |
| Gana X | Collection of Adverse Events | Subjects with at least one SADE: | With | 0 Participants |
| Gana X | Collection of Adverse Events | Subjects with at least one SADE: | Without | 50 Participants |
Secondary
Collection of Injection Site Reactions
Injection site reactions are usual signs reported after injection and consist on the evaluation of the following signs : Redness / Erythema, Pain / Tenderness, Induration / Firmness, Swelling / Edema, Lumps / Bumps, Bruising, Itching, Coloration, Pigmentation / Discoloration. Data presented are a percentage of subjects presenting at least one ISR of any severity evaluated by the investigator
Time frame: Day 0, Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24]
Population: Safety population - any subject having used the investigational device
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana X | Collection of Injection Site Reactions | D0 after initial injection | At least one sign | 32 Participants |
| Gana X | Collection of Injection Site Reactions | D0 after initial injection | No sign | 18 Participants |
| Gana X | Collection of Injection Site Reactions | M11/2 before touch-up | At least one sign | 2 Participants |
| Gana X | Collection of Injection Site Reactions | M11/2 before touch-up | No sign | 48 Participants |
| Gana X | Collection of Injection Site Reactions | M11/2 after touch-up | At least one sign | 40 Participants |
| Gana X | Collection of Injection Site Reactions | M11/2 after touch-up | No sign | 5 Participants |
| Gana X | Collection of Injection Site Reactions | M6 | At least one sign | 7 Participants |
| Gana X | Collection of Injection Site Reactions | M6 | No sign | 40 Participants |
| Gana X | Collection of Injection Site Reactions | M9 | At least one sign | 4 Participants |
| Gana X | Collection of Injection Site Reactions | M9 | No sign | 36 Participants |
| Gana X | Collection of Injection Site Reactions | M12 | At least one sign | 6 Participants |
| Gana X | Collection of Injection Site Reactions | M12 | No sign | 33 Participants |
| Gana X | Collection of Injection Site Reactions | M18 | At least one sign | 9 Participants |
| Gana X | Collection of Injection Site Reactions | M18 | No sign | 27 Participants |
| Gana X | Collection of Injection Site Reactions | M24 | At least one sign | 6 Participants |
| Gana X | Collection of Injection Site Reactions | M24 | No sign | 31 Participants |
Secondary
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Percentage of participants with an improvement on GAIS. A responder is defined as a subject having Improved, Much improved or Very much improved score according to GAIS.
Time frame: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included in the study with at least a post-basal value.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M11/2 | Responder | 36 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M11/2 | Not Responder | 14 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M6 | Responder | 46 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M6 | Not Responder | 1 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M9 | Responder | 38 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M9 | Not Responder | 2 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M12 | Responder | 37 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M12 | Not Responder | 2 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M18 | Responder | 26 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M18 | Not Responder | 9 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M24 | Responder | 26 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the independent blind evaluator at M24 | Not Responder | 11 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M11/2 | Responder | 27 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M11/2 | Not Responder | 22 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M6 | Responder | 42 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M6 | Not Responder | 5 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M9 | Responder | 32 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M9 | Not Responder | 6 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M12 | Responder | 33 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M12 | Not Responder | 5 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M18 | Responder | 29 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M18 | Not Responder | 7 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M24 | Responder | 28 Participants |
| Gana X | Global Aesthetic Improvement Scale (GAIS) Responder Rate | Evaluated by the subject at M24 | Not Responder | 9 Participants |
Secondary
Injector Satisfaction
The investigator who will inject the product will complete a questionnaire for each participant.
Time frame: After initial injection (Day 0)
Population: Intent To Treat population - any subject included in the study with at least a post-basal value
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana X | Injector Satisfaction | Mouldability | Very dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Ease of injection | Very satisfied | 34 Participants |
| Gana X | Injector Satisfaction | Ease of injection | satisfied | 13 Participants |
| Gana X | Injector Satisfaction | Ease of injection | Somewhat satisfied | 2 Participants |
| Gana X | Injector Satisfaction | Ease of injection | Somewhat dissatisfied | 1 Participants |
| Gana X | Injector Satisfaction | Ease of injection | Dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Ease of injection | Very dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Mouldability | Very satisfied | 28 Participants |
| Gana X | Injector Satisfaction | Mouldability | satisfied | 21 Participants |
| Gana X | Injector Satisfaction | Mouldability | Somewhat satisfied | 1 Participants |
| Gana X | Injector Satisfaction | Mouldability | Somewhat dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Mouldability | Dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Ease of product positioning | Very satisfied | 29 Participants |
| Gana X | Injector Satisfaction | Ease of product positioning | satisfied | 14 Participants |
| Gana X | Injector Satisfaction | Ease of product positioning | Somewhat satisfied | 7 Participants |
| Gana X | Injector Satisfaction | Ease of product positioning | Somewhat dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Ease of product positioning | Dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Ease of product positioning | Very dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Immediate result | Very satisfied | 22 Participants |
| Gana X | Injector Satisfaction | Immediate result | satisfied | 18 Participants |
| Gana X | Injector Satisfaction | Immediate result | Somewhat satisfied | 9 Participants |
| Gana X | Injector Satisfaction | Immediate result | Somewhat dissatisfied | 1 Participants |
| Gana X | Injector Satisfaction | Immediate result | Dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Immediate result | Very dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Result after massage | Very satisfied | 23 Participants |
| Gana X | Injector Satisfaction | Result after massage | satisfied | 23 Participants |
| Gana X | Injector Satisfaction | Result after massage | Somewhat satisfied | 4 Participants |
| Gana X | Injector Satisfaction | Result after massage | Somewhat dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Result after massage | Dissatisfied | 0 Participants |
| Gana X | Injector Satisfaction | Result after massage | Very dissatisfied | 0 Participants |
Secondary
Percentage of Satisfied Participants
Percentage of participants with positive answers to an internal questionnaire
Time frame: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24
Population: Intent To Treat population - any subject included in the study with at least a post-basal value
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M11/2? | Satisfied | 31 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M11/2? | Not satisfied | 19 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M6? | Satisfied | 39 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M6? | Not satisfied | 8 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M9? | Satisfied | 33 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M9? | Not satisfied | 7 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M12? | Satisfied | 33 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M12? | Not satisfied | 6 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M18? | Satisfied | 31 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M18? | Not satisfied | 5 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M24? | Satisfied | 32 Participants |
| Gana X | Percentage of Satisfied Participants | Are you satisfied with how your buttocks looks at M24? | Not satisfied | 5 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M11/2 | Satisfied | 33 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M11/2 | Not satisfied | 17 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M6 | Satisfied | 40 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M6 | Not satisfied | 7 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M9 | Satisfied | 32 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M9 | Not satisfied | 8 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M12 | Satisfied | 32 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M12 | Not satisfied | 6 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M18 | Satisfied | 30 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M18 | Not satisfied | 6 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M24 | Satisfied | 32 Participants |
| Gana X | Percentage of Satisfied Participants | The result is aesthetically satisfying at M24 | Not satisfied | 5 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M11/2 | Satisfied | 41 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M11/2 | Not satisfied | 9 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M6 | Satisfied | 44 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M6 | Not satisfied | 3 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M9 | Satisfied | 37 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M9 | Not satisfied | 3 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M12 | Satisfied | 31 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M12 | Not satisfied | 7 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M18 | Satisfied | 35 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M18 | Not satisfied | 1 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M24 | Satisfied | 35 Participants |
| Gana X | Percentage of Satisfied Participants | The result is natural at M24 | Not satisfied | 2 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M11/2 | Satisfied | 31 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M11/2 | Not satisfied | 18 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M6 | Satisfied | 39 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M6 | Not satisfied | 8 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M9 | Satisfied | 30 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M9 | Not satisfied | 10 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M12 | Satisfied | 31 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M12 | Not satisfied | 7 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M18 | Satisfied | 28 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M18 | Not satisfied | 8 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M24 | Satisfied | 29 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks volume are restored at M24 | Not satisfied | 8 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M11/2 | Satisfied | 30 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M11/2 | Not satisfied | 20 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M6 | Satisfied | 33 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M6 | Not satisfied | 14 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M9 | Satisfied | 29 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M9 | Not satisfied | 11 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M12 | Satisfied | 31 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M12 | Not satisfied | 7 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M18 | Satisfied | 27 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M18 | Not satisfied | 9 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M24 | Satisfied | 30 Participants |
| Gana X | Percentage of Satisfied Participants | The buttocks skin laxity is improved at M24 | Not satisfied | 7 Participants |