Adipose Tissue AtrophyNCT04012814
Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction
A study testing Venus Bliss in people with Adipose Tissue Atrophy, run by Venus Concept at 5 sites in United States.
Trial summary
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue Atrophy
- What is being tested?
- Venus Bliss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Sep 2019to 22 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks.
- 3. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.
- 5. Able and willing to comply with the treatment/follow-up schedule and requirements.
- 6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
Who cannot join
- 1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
- 2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- 3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study.
- 4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- 5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
- 6. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
Show all 13Show fewer
- 7. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate).
- 8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
- 9. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.
- 10. Tattoos in the treatment area. 11. Poor skin quality (severe laxity). 12. Abdominal wall, muscular abnormality or hernia on physical examination. 13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study.
- 14. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
- 15. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
- 16. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
aFresh Medispa
Chicago, Illinois, 60026
UT Southwestern Medical Center Department of Plastic Surgery
Dallas, Texas, 75390
Berman Skin Institute
Los Altos, California, 94022
Laser & Skin Surgery Medical Group, Inc
Sacramento, California, 95816
Batra Dermatology
Santa Monica, California, 90404
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
Read the detailed description
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields, and vacuum-assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive 3 study treatments of the diode laser and 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency. Subjects will be followed at twelve weeks post-final diode treatment. The twelve-week post-treatment outcome will be compared to the baseline.
- Conditions
- Adipose Tissue Atrophy
- Being tested
- Venus Bliss
- Keywords
- fat, abdomen fat, flank fat, body contouring
- Medical subject headings
- Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus BlissDevice
The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.
| Study group | Role | What they receive |
|---|---|---|
| Subject treatment group | Experimental | Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24. Receives: Device: Venus Bliss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aesthetic Appearance From Baseline
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change)
Measured: Week 24
Secondary outcomes (2)
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale
To assess subject satisfaction with treatment at the Week 24 visit using the 5-point Likert Subject Satisfaction Scale: 0 - very dissatisfied, 1 - dissatisfied, 2 - neutral, 3 - satisfied, 4 - very satisfied.
Measured: Week 24
Change in Fat Thickness
Fat thickness was measured using ultrasound at one clinical site (14 subjects in total). Change between Week 0 and Week 24 measurements is shown.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start19 Sep 2019
- Primary completion22 Oct 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adipose Tissue AtrophyStudies 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
- Model description
- Up to 200 subjects will be enrolled in the study to receive 3 Diode and 3 RF treatments.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoni Iger, PhD, Study director, Venus Concept LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012814
- Sponsor's protocol ID
- BL0319
- Status last verified
- Apr 2024
- First submitted
- 4 Jul 2019
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks
- ClinicalTrials.gov ID
- NCT04012814
- Acronym / sponsor ID
- BL0319
- Conditions
- Adipose Tissue Atrophy
- Keywords
- fat, abdomen fat, flank fat, body contouring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
Detailed description
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields, and vacuum-assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive 3 study treatments of the diode laser and 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency. Subjects will be followed at twelve weeks post-final diode treatment. The twelve-week post-treatment outcome will be compared to the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 200 subjects will be enrolled in the study to receive 3 Diode and 3 RF treatments.
| Arm | Type | Receives |
|---|---|---|
| Subject treatment group | Experimental | Device: Venus BlissTreatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks.
- 3. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.
- 5. Able and willing to comply with the treatment/follow-up schedule and requirements.
- 6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
Key exclusion criteria (13 listed)
- 1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
- 2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- 3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study.
- 4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- 5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
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 |
|---|---|---|
| Venus BlissThe FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening. | Device | Subject treatment group |
Primary outcome
Change in Aesthetic Appearance From Baseline
Time frame: Week 24
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change)
2 secondary outcomes
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale
Time frame: Week 24
Change in Fat Thickness
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share data with other researchers
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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.
Yoni Iger, PhD study director
Venus Concept LTD
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Bliss in people with Adipose Tissue Atrophy, run by Venus Concept at 5 sites in United States.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aesthetic Appearance From Baseline (time frame: Week 24). 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 23 Apr 2024.