Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty

Adipose Tissue Atrophy Clinical Trial

Official title:

Analysis of the Performance of 1060 nm Diode Laser and Radiofrequency Intended for Fat Reduction Prior to Abdominoplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04616898
• Other study ID #: BL0519
• Secondary ID: STU2019-1160
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Venus Concept
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adipose Tissue Atrophy
• Atrophy

Intervention

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.

Locations

Country	Name	City	State
United States	Dr. Brian Kinney Plastic Surgeon	Beverly Hills	California
United States	University of Texas Southwestern	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Venus Concept	University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment
Primary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment
Primary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment
Secondary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment
Secondary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment
Secondary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment
Secondary	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.	Day 1, Day 7, Day 14, Day 20-30 post-treatment