Adipose Tissue AtrophyNCT04616898
Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
A study testing Venus Bliss in people with Adipose Tissue Atrophy, run by Venus Concept at 2 sites in United States.
Trial summary
To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue Atrophy
- What is being tested?
- Venus Bliss
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2020to 27 Nov 2023
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are currently seeking abdominoplasty surgery and are consenting to their tissue that is being excised, to be tested
- Informed consent agreement signed by the subject.
- Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I-V).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Who cannot join
- Pregnant and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after the treatment session.
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- Having received collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study.
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- Having received Botox in the treated area within 6 months of treatment or during the study.
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Vascular lesion, tattoo or permanent make-up in the treated area.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three month prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dr. Brian Kinney Plastic Surgeon
Beverly Hills, California, 90212
University of Texas Southwestern
Dallas, Texas, 75390
About this study
Official title: Analysis of the Performance of 1060 nm Diode Laser and Radiofrequency Intended for Fat Reduction Prior to Abdominoplasty
To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.
Read the detailed description
The Primary Objectives of this protocol are to evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency for use in aesthetic dermatological procedures requiring the ablation, excision, incision, or coagulation of soft tissue. Efficacy will be analyzed through histological and molecular analysis. Safety will be analyzed by monitoring the occurrence of any adverse events.
- Conditions
- Adipose Tissue Atrophy
- Being tested
- Venus Bliss
- Keywords
- Adipose, Fat
- 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 Venus Bliss™ system is an aesthetic medical device designed to non-invasively reduce subcutaneous adipose tissue of the abdominal area and flanks. It is intended for use in individuals with a Body Mass Index (BMI) of 30 or less. The device consists of an external treatment component and an internal control component. The treatment console is a 1060nm diode laser applicator and a radio frequency applicator. In addition, a Bliss Belt is provided with the system to properly secure one or more applicators to the patient's body during treatment. Finally, the touchscreen monitor is used by the clinician to control the setting display on the main console. It also keeps the clinician informed of the device's status and operating parameters.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser Treatment Only | Active comparator | Group 1: Patient 1- Laser Only This patient will present 20+, 14, 7, and 1 days prior to his/her scheduled abdominoplasty. Between 20 and 30 days prior, the patient will receive the first laser treatment on the 20+ day site 1. 14 days prior, the patient will receive laser treatment on the 14 day site 2. 7 days prior, the patient will receive laser treatment on the 7 day site 3. 1 day prior to the scheduled abdominoplasty, the patient will receive laser treatment on the 24 hour site 4. Receives: Device: Venus Bliss |
| Diode Laser and RadioFrequency Treatment | Active comparator | This patient will present 14 days and 7 days prior to his/her scheduled abdominoplasty. 14 days prior, the patient will be treated at site 1 with the laser and radiofrequency and site 3 with the laser only. 7 days prior, the patient will be treated at site 2 with the laser and radiofrequency and site 4 with the laser only. Receives: Device: Venus Bliss |
| Multiple Diode Treatments | Active comparator | These patients will present for three treatments, each four weeks apart, with the abdominoplasty scheduled four weeks following the last laser treatment. These patients will receive laser treatment every four weeks for twelve weeks on the sites labelled Multiple Tx below (sites 1 and 2) on Days -90, -60, and -30 prior to abdominoplasty. At the final treatment (Day -30), two additional diodes will be placed on the sites labelled Single Tx below (sites 3 and 4). 4 diodes total will be used at this visit. Four weeks following this last treatment, the scheduled abdominoplasty will be performed and the pannus containing the treated tissue will be excised. Receives: Device: Venus Bliss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in elastin as determined by histology on biopsied tissues
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in collagen as determined by histology on biopsied tissues
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in hyaluronic acid as determined by histology on biopsied tissues
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Secondary outcomes (4)
Changes in elastin as a result of treatment measured by quantification of gene expression
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in collagen as a result of treatment measured by quantification of gene expression
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in hyaluronic acid as a result of treatment measured by quantification of gene expression
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Quantification of the immune response following treatment
Biopsies of the treated tissue will be taken prior to treatment and post-treatment for gene expression analysis. This analysis will identify gene expression related to the immune response.
Measured: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jul 2020
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For this study, there will be three treatment groups in total. Details of each treatment are depicted in the addendum below. Groups 1 (laser only- 6 visits) and 2 (laser plus radiofrequency- 4 visits) will each consist of one patient. Group 3 (multiple vs. single laser treatments - 5 visits) will consist of three patients.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Jeffrey Kenkel, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616898
- Sponsor's protocol ID
- BL0519
- Other IDs
- STU2019-1160
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2020
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Performance of 1060 nm Diode Laser and Radiofrequency Intended for Fat Reduction Prior to Abdominoplasty
- ClinicalTrials.gov ID
- NCT04616898
- Acronym / sponsor ID
- BL0519
- Conditions
- Adipose Tissue Atrophy
- Keywords
- Adipose, Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 5 Nov 2020 (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.
To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.
Detailed description
The Primary Objectives of this protocol are to evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency for use in aesthetic dermatological procedures requiring the ablation, excision, incision, or coagulation of soft tissue. Efficacy will be analyzed through histological and molecular analysis. Safety will be analyzed by monitoring the occurrence of any adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- For this study, there will be three treatment groups in total. Details of each treatment are depicted in the addendum below. Groups 1 (laser only- 6 visits) and 2 (laser plus radiofrequency- 4 visits) will each consist of one patient. Group 3 (multiple vs. single laser treatments - 5 visits) will consist of three patients.
| Arm | Type | Receives |
|---|---|---|
| Diode Laser Treatment Only | Active comparator | Device: Venus BlissGroup 1: Patient 1- Laser Only This patient will present 20+, 14, 7, and 1 days prior to his/her scheduled abdominoplasty. Between 20 and 30 days prior, the patient will receive the first laser treatment on the 20+ day site 1. 14 days prior, the patient will receive laser treatment on the 14 day site 2. 7 days prior, the patient will receive laser treatment on the 7 day site 3. 1 day prior to the scheduled abdominoplasty, the patient will receive laser treatment on the 24 hour site 4. |
| Diode Laser and RadioFrequency Treatment | Active comparator | Device: Venus BlissThis patient will present 14 days and 7 days prior to his/her scheduled abdominoplasty. 14 days prior, the patient will be treated at site 1 with the laser and radiofrequency and site 3 with the laser only. 7 days prior, the patient will be treated at site 2 with the laser and radiofrequency and site 4 with the laser only. |
| Multiple Diode Treatments | Active comparator | Device: Venus BlissThese patients will present for three treatments, each four weeks apart, with the abdominoplasty scheduled four weeks following the last laser treatment. These patients will receive laser treatment every four weeks for twelve weeks on the sites labelled Multiple Tx below (sites 1 and 2) on Days -90, -60, and -30 prior to abdominoplasty. At the final treatment (Day -30), two additional diodes will be placed on the sites labelled Single Tx below (sites 3 and 4). 4 diodes total will be used at this visit. Four weeks following this last treatment, the scheduled abdominoplasty will be performed and the pannus containing the treated tissue will be excised. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who are currently seeking abdominoplasty surgery and are consenting to their tissue that is being excised, to be tested
- Informed consent agreement signed by the subject.
- Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I-V).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Key exclusion criteria (21 listed)
- Pregnant and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after the treatment session.
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
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 Venus Bliss™ system is an aesthetic medical device designed to non-invasively reduce subcutaneous adipose tissue of the abdominal area and flanks. It is intended for use in individuals with a Body Mass Index (BMI) of 30 or less. The device consists of an external treatment component and an internal control component. The treatment console is a 1060nm diode laser applicator and a radio frequency applicator. In addition, a Bliss Belt is provided with the system to properly secure one or more applicators to the patient's body during treatment. Finally, the touchscreen monitor is used by the clinician to control the setting display on the main console. It also keeps the clinician informed of the device's status and operating parameters. | Device | Diode Laser Treatment Only, Diode Laser and RadioFrequency Treatment, Multiple Diode Treatments |
Primary outcome
Changes in elastin as determined by histology on biopsied tissues
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Changes in collagen as determined by histology on biopsied tissues
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
Changes in hyaluronic acid as determined by histology on biopsied tissues
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Relative changes in protein abundance of biopsy samples taken post treatment compared to control or untreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline is calculated at each time frame.
4 secondary outcomes
Changes in elastin as a result of treatment measured by quantification of gene expression
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in collagen as a result of treatment measured by quantification of gene expression
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Changes in hyaluronic acid as a result of treatment measured by quantification of gene expression
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Quantification of the immune response following treatment
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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.
Jeffrey Kenkel, MD principal investigator
University of Texas
2 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 2 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 21 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in elastin as determined by histology on biopsied tissues (time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment). The study lists 3 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 21 Aug 2024.