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

NCT04616898 | Completed FDA Device

• 2 other identifiers: BL0519STU2019-1160
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Adipose Tissue Atrophy

Keywords

Adipose; Fat

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Changes in elastin as a result of treatment measured by quantification of gene expression

  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

  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

  Day 1, Day 7, Day 14, Day 20-30 post-treatment

• Quantification of the immune response following treatment

  Day 1, Day 7, Day 14, Day 20-30 post-treatment

Study Arms (3)

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.

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.

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.

Device: Venus Bliss

Interventions

Venus Bliss DEVICE

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.

Diode Laser Treatment Only; Diode Laser and RadioFrequency Treatment; Multiple Diode Treatments

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Venus Concept: lead
• University of Texas: collaborator

Study Sites (2)

Dr. Brian Kinney Plastic Surgeon

Beverly Hills, California, 90212, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Platelet Glycoprotein IV Deficiency

Study Officials

• Jeffrey Kenkel, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: November 5, 2020
• Study Start: July 1, 2020
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)