Back to resultsAnalysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
Primary Purpose
Adipose Tissue Atrophy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venus Bliss
Sponsored by
About this trial
This is an interventional basic science trial for Adipose Tissue Atrophy focused on measuring Adipose, Fat
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Dr. Brian Kinney Plastic Surgeon
- University of Texas Southwestern
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Diode Laser Treatment Only
Diode Laser and RadioFrequency Treatment
Multiple Diode Treatments
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04616898
First Posted
July 21, 2020
Last Updated
April 24, 2023
Sponsor
Venus Concept
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT04616898
Brief Title
Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
Official Title
Analysis of the Performance of 1060 nm Diode Laser and Radiofrequency Intended for Fat Reduction Prior to Abdominoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
Collaborators
University of Texas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adipose Tissue Atrophy
Keywords
Adipose, Fat
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diode Laser Treatment Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diode Laser and RadioFrequency Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multiple Diode Treatments
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Venus Bliss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in elastin as determined by histology on biopsied tissues
Description
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
Title
Changes in collagen as determined by histology on biopsied tissues
Description
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
Title
Changes in hyaluronic acid as determined by histology on biopsied tissues
Description
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
Secondary Outcome Measure Information:
Title
Changes in elastin as a result of treatment measured by quantification of gene expression
Description
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
Title
Changes in collagen as a result of treatment measured by quantification of gene expression
Description
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
Title
Changes in hyaluronic acid as a result of treatment measured by quantification of gene expression
Description
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
Title
Quantification of the immune response following treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kenkel, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Brian Kinney Plastic Surgeon
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
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