Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)

NCT03756350 | Completed Results FDA Device

• 1 other identifier: CS1317
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Conditions

Fat Atrophy

Keywords

abdomen; adipose; fat

Outcome Measures

Primary Outcomes (1)

• Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators

  Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks

  Week 12 vs baseline

Secondary Outcomes (3)

• Change in Fat Thickness

  week 12

• Subject Satisfaction

  Week 12

• Treatment Pain

  Week 1

Study Arms (1)

Treatment subjects

EXPERIMENTAL

Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.

Device: 1060nm diode laser

Interventions

1060nm diode laser DEVICE

Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Treatment subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to read, understand and voluntarily provide written informed consent
• healthy male or female \> 18 years of age seeking treatment for unwanted fat in the abdomen
• BMI score is less then 30
• agree to not making any major changes in their diet or lifestyle during the course of the study
• able and willing to comply with the treatment / follow up schedule and requirements
• women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline

You may not qualify if:

• pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months
• any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months
• history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study
• History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding
• Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment
• Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions
• Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)
• Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder
• Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections
• Tattoos in the treatment area
• Poor quality skin (laxity)
• Abdominal wall, muscular abnormality or hernia on physical examination
• Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
• Participation in another clinical study involving the same anatomical areas within the last 6 months
• History of keloid and hypertrophic scar formation or poor wound healing in the treatment area

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (2)

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Southwestern Medical Center Department of Plastic Surgery

Dallas, Texas, 75390, United States

Location

Related Publications (4)

• Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.

  PMID: 28103642 RESULT

• Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.

  PMID: 28902034 RESULT

• McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.

  PMID: 21779417 RESULT

• Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.

  PMID: 28095532 RESULT

MeSH Terms

Conditions

Platelet Glycoprotein IV Deficiency

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. Matthew Gronski
• Organization: Venus Concept

mgronski@venusconcept.com

(888) 907-0115

Study Officials

• Suzanne Kilmer, MD

  Skin and Laser Surgery Center of Northern California

  PRINCIPAL INVESTIGATOR

• Jeffery Kenkel, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded reviewer will evaluate the pre and post photos
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 14, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)