Subcutaneous Fat DisorderNCT04090853
Subject Evaluation of a 1064nm Diode Laser/RF
A study testing Venus Bliss in people with Subcutaneous Fat Disorder, run by Venus Concept at 3 sites in United States.
Trial summary
Open-label, baseline-controlled, multi-center study evaluating a 1064 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
- Subcutaneous Fat Disorder
- 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
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2019to 8 Jul 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks and or abdomen
- BMI score is less than 35.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- 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
- Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
- Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- 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.
- History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
- 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.
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- 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).
- Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
- 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.
- Tattoos in the treatment area.
- Poor skin quality (severe laxity).
- Abdominal wall, muscular abnormality or hernia on physical examination.
- Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study.
- History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
- As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
- 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
3 sites in 1 country.
United States3 sites
Shah Aesthetic Surgery
Denver, Colorado, 80206
Medical Management Solutions INC
Foxborough, Massachusetts, 02035
SRS Dermatology
Woodmere, New York, 11598
About this study
Official title: Subject Evaluation of the Efficacy of a 1064 nm Diode Laser, Pulsed Electro-Magnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Contouring of the Abdomen and Flanks
Open-label, baseline-controlled, multi-center study evaluating a 1064 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
The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes.
- Conditions
- Subcutaneous Fat Disorder
- Being tested
- Venus Bliss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus BlissDevice
The investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1064 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 |
|---|---|---|
| Patient Treatment Group | Other | Up to three Diode and Radio Frequency treatments and up to three additional radio frequency treatments will be performed per patient at the discretion of the principal investigator. Diode treatments will be spaced six weeks apart while the radio frequency treatments will be spaced between 2-3 weeks apart. Receives: Device: Venus Bliss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Overall Satisfaction
Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions
Measured: Week 26
Patient Treatment Satisfaction
Patients rate their treatment satisfaction using a 5 point Likert Scale. The Likert scale ranges from 1 = very unsatisfied 2 = unsatisfied 3 = neutral 4 = satisfied 5 = very satisfied
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Oct 2019
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: Slow enrolment and Covid19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous Fat DisorderStudies 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
- Single group assessed patient feedback regarding satisfaction post treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoni Iger, Study director, Venus Concept LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090853
- Sponsor's protocol ID
- BL1119
- Status last verified
- May 2023
- First submitted
- 12 Sep 2019
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject Evaluation of the Efficacy of a 1064 nm Diode Laser, Pulsed Electro-Magnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Contouring of the Abdomen and Flanks
- ClinicalTrials.gov ID
- NCT04090853
- Acronym / sponsor ID
- BL1119
- Conditions
- Subcutaneous Fat Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow enrolment and Covid19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 16 Sep 2019 (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.
Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
Detailed description
The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assessed patient feedback regarding satisfaction post treatment
| Arm | Type | Receives |
|---|---|---|
| Patient Treatment Group | Other | Device: Venus BlissUp to three Diode and Radio Frequency treatments and up to three additional radio frequency treatments will be performed per patient at the discretion of the principal investigator. Diode treatments will be spaced six weeks apart while the radio frequency treatments will be spaced between 2-3 weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks and or abdomen
- BMI score is less than 35.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- 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 (16 listed)
- Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
- Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- 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.
- History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- 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 investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1064 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 | Patient Treatment Group |
Primary outcome
Patient Overall Satisfaction
Time frame: Week 26
Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions
Patient Treatment Satisfaction
Time frame: Week 26
Patients rate their treatment satisfaction using a 5 point Likert Scale. The Likert scale ranges from 1 = very unsatisfied 2 = unsatisfied 3 = neutral 4 = satisfied 5 = very satisfied
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: No
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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 study director
Venus Concept LTD
3 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 Subcutaneous Fat Disorder, run by Venus Concept at 3 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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient Overall Satisfaction (time frame: Week 26). The study lists 2 primary outcomes in all. 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 8 May 2023.