An interventional study of Venus Bliss in Adipose Tissue Atrophy, sponsored by Venus Concept. Completed at 2 sites in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Venus Concept · Not applicable, Interventional, and Basic science
To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.
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.
Venus Concept is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Venus Bliss
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.
Device: Venus Bliss
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.
Device: Venus Bliss
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
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.
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
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.
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
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.
Time frame: 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.
Time frame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Nov 2023, 40 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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