🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-26)

A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

🟢 Recruiting Protocol / Phase N/A ⚙️ Medical Device Protocol Sponsor: Bausch Health Americas, Inc.

🩺 Protocol Summary

A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System

Primary Research Facility: Laser & Skin Surgery Center of Northern California (Sacramento, California)

📋 Preliminary Self-Screener

0 of 3 Answered

Answer all 3 basic criteria below to see your preliminary screening result:

Healthy adult volunteer with no active chronic exclusionary medical conditions?

Aged between **30 Years** and **60 Years**?

Able to attend study appointments at **Laser & Skin Surgery Center of Northern California** (Sacramento, California) or affiliated sites?

📍 Primary Site Map

Site: Laser & Skin Surgery Center of Northern California — Sacramento, California

📍 All Participating Trial Locations (7 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Laser & Skin Surgery Center of Northern California — Sacramento, California • Contact: (916) 768-0400

2. Cosmetic Laser Dermatology — San Diego, California • Contact: (858) 657-1004

3. Cosmetic Laser Dermatology — San Diego, California • Contact: (858) 657-1002

4. Chicago Cosmetic Surgery and Dermatology — Chicago, Illinois • Contact: (312) 245-9965

5. SkinCare Physicians — Chestnut Hill, Massachusetts • Contact: (617) 731-1600

6. Union Square Laser Dermatology — New York, New York • Contact: (212) 366-5400

7. Dermatology and Laser Surgery Center — Houston, Texas • Contact: (713) 900-3900

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07187297 • Last Synced: 2026-08-26

View on ClinicalTrials.gov ↗