Multi-Center Traditional Feasibility Study of Radiofrequency Device

NCT04584099 | Terminated Results FDA Device

• 1 other identifier: CYN20-FIRM-HISTO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the abdominal area.

Conditions

Body Fat

Outcome Measures

Primary Outcomes (1)

• Histology of Biopsy

  Samples will be assessed independently and may be assessed for normal structures, cell viability, vascular injury, and overall morphologic traits, injury, and any indications of the healing response.

  Up to 30 days post last treatment

Study Arms (1)

Biopsy Removed Post Tx

EXPERIMENTAL

All subjects had one radiofrequency treatment before scheduled biopsy or abdominoplasty on tissue to be removed during abdominoplasty immediately post treatment, 10 days post treatment, 20 days post treatment, and/or 30 days post treatment.

Device: Radiofrequency device treatment

Interventions

Radiofrequency device treatment DEVICE

TempSure firm

Biopsy Removed Post Tx

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy male or female between the age of 18 - 55 years old.
• Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

You may not qualify if:

• Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
• The subject has a cut, wound, or infected skin on the area to be treated.
• The subject is on local, oral, or systemic anesthetic agents.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• Cautionary Criteria:
• The subject has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
• The subject has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client's cardiologist must be consulted prior to treatment.
• NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.
• If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any metal implant that could conduct heat from the Smart Handpiece or surgical handpiece.
• The subject is allergic to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the neutral pad site and an over the counter solution may be used to treat the area.
• The subject is allergic to gold, such as the metallic covering of the TempSure handpieces.
• The subject is allergic to corn, such as the corn derivative ingredient in Parker Aquasonic Gel.
• If the subject has an unhealthy expectation of the results - this is not plastic surgery and all subject should be fully informed of the treatment's expected results.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (2)

Bass Plastic Surgery PLLC

New York, New York, 10065, United States

Location

Aesthetic Pavilion

Staten Island, New York, 103206, United States

Location

Related Publications (1)

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

  PMID: 31896400 BACKGROUND

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(978) 256-4200

Study Officials

• Jennifer Civiok

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 12, 2020
• Study Start: August 25, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)