Body Fat DistributionNCT03312946
Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
A study testing Modellata in people with Body Fat Distribution and Cellulitis, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.
Trial summary
OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical equipment in improving body contour and appearance of cellulite. SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with cellulitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Fat Distribution, Cellulitis
- What is being tested?
- Modellata
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Oct 2017to 4 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female gender, over 18 years of age;
- With body mass index considered eutrophic;
- Cellulite carriers;
- Non smokers;
- That they agree to participate and sign the TCLE.
Who cannot join
- Male gender;
- Menopausal women;
- Have undergone aesthetic treatment in the gluteal region and thighs in the last 6 months;
- Patients with skin lesions, such as dermatitis and dermatoses;
- Patients with capillary fragility;
- Patients with acute deep vein thrombosis (DVT);
- On or near cancerous lesions;
- Patients with cardiac pacemaker or other implanted electronic device
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ibramed - Indústria Brasileira de Equipamentos Médicos
Amparo, São Paulo, 13901-080
Débora o Modena, MsC, 19991319016, de_modena@yahoo.com.br
About this study
OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical equipment in improving body contour and appearance of cellulite.
SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with cellulitis. Patients will be submitted to data collection and evaluation and before and after vibration-oscillatory therapy.
Read more
HYPOTHESES: Patients are expected to show improvement in body contour and cellulite after vibration-oscillatory therapy.
STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measures will be used. Tukey's test will be used to compare the groups. The significance level adopted for the statistical tests will be 5% or p <0.05.
Read the detailed description
After approval by the institutional committee of Research Ethics, the subjects will be approached by the researcher responsible on the day of their evaluation, where they completed the registration form, after a brief analysis of the inclusion and exclusion criteria of the present study, the individuals included in the study will be collection of anthropometric data: weight, height, BMI, perimeter of the treated region, assessment of the degree of gynoid lipodystrophy, clinical inspection and photographic study of the treated area, ultrasound examination to assess the thickness of the dermis and hypodermis and the examination with Cutometer ® to assess the viscoelasticity of the skin.
Patients will be divided according to the degree of cellulite they present and will be treated with vibration therapy, such as the Modellata® electromedical equipment (Ibramed- Brazilian Industry of Electronic Equipment), being performed three times a week for two months totaling 16 sessions by a dermato-functional physiotherapist.
Data collection and evaluation will be performed before and after treatment.
- Conditions
- Body Fat Distribution, Cellulitis
- Being tested
- Modellata
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModellataDevice
treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment oscillating vibro | Experimental | treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks. Being performed twice a week, with a total duration of 50 minutes to the session, being 10 sessions total to end the treatment. Receives: Device: Modellata |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve body contour
Perimetry, photos, and ultrasound
Measured: 1 hour per session (10 sessions 5 weeks).
Secondary outcomes (1)
Improve appearance of cellulite
perimetry, photos, ultra son, degree of cellulite
Measured: 1 hour per session (10 sessions 5 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start13 Oct 2017
- Primary completion4 Dec 2017 (estimated)
- Study completion4 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Fat DistributionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indústria Brasileira Equipamentos Médicos - IBRAMED
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312946
- Sponsor's protocol ID
- Ibramedmodellata
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
- ClinicalTrials.gov ID
- NCT03312946
- Acronym / sponsor ID
- Ibramedmodellata
- Conditions
- Body Fat Distribution, Cellulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indústria Brasileira Equipamentos Médicos - IBRAMEDIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 4 Dec 2017 (estimated)
- Study completion
- 4 Feb 2018 (estimated)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical equipment in improving body contour and appearance of cellulite.
SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with cellulitis. Patients will be submitted to data collection and evaluation and before and after vibration-oscillatory therapy.
HYPOTHESES: Patients are expected to show improvement in body contour and cellulite after vibration-oscillatory therapy.
STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measures will be used. Tukey's test will be used to compare the groups. The significance level adopted for the statistical tests will be 5% or p <0.05.
Detailed description
After approval by the institutional committee of Research Ethics, the subjects will be approached by the researcher responsible on the day of their evaluation, where they completed the registration form, after a brief analysis of the inclusion and exclusion criteria of the present study, the individuals included in the study will be collection of anthropometric data: weight, height, BMI, perimeter of the treated region, assessment of the degree of gynoid lipodystrophy, clinical inspection and photographic study of the treated area, ultrasound examination to assess the thickness of the dermis and hypodermis and the examination with Cutometer ® to assess the viscoelasticity of the skin.
Patients will be divided according to the degree of cellulite they present and will be treated with vibration therapy, such as the Modellata® electromedical equipment (Ibramed- Brazilian Industry of Electronic Equipment), being performed three times a week for two months totaling 16 sessions by a dermato-functional physiotherapist.
Data collection and evaluation will be performed before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment oscillating vibro | Experimental | Device: Modellatatreatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks. Being performed twice a week, with a total duration of 50 minutes to the session, being 10 sessions total to end the treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female gender, over 18 years of age;
- With body mass index considered eutrophic;
- Cellulite carriers;
- Non smokers;
- That they agree to participate and sign the TCLE.
Key exclusion criteria (8 listed)
- Male gender;
- Menopausal women;
- Have undergone aesthetic treatment in the gluteal region and thighs in the last 6 months;
- Patients with skin lesions, such as dermatitis and dermatoses;
- Patients with capillary fragility;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modellatatreatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks. | Device | Treatment oscillating vibro |
Primary outcome
Improve body contour
Time frame: 1 hour per session (10 sessions 5 weeks).
Perimetry, photos, and ultrasound
1 secondary outcome
Improve appearance of cellulite
Time frame: 1 hour per session (10 sessions 5 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Body Fat Distribution
Enrolling by invitation
MRI Assessment of Body Composition in Bariatric Surgery
Obesity (BMI>30)
RecruitingObservational study
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
Cystic Fibrosis
Active, not recruiting
Epigenetic Regulation of Human Adipose Tissue Distribution
Obesity
RecruitingPhase 2
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
Not yet recruiting
A Study of Body Fat Distribution and Airway Mechanics in Healthy Adults
Healthy Volunteers Only
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibramed - Indústria Brasileira de Equipamentos Médicos
Amparo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modellata in people with Body Fat Distribution and Cellulitis, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve body contour (time frame: 1 hour per session (10 sessions 5 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.