CoolSculpting for Fat Reduction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests CoolSculpting Elite, a treatment designed to reduce fat in specific areas such as under the chin, inner thighs, and the back/bra area. The goal is to gather more information about its safety and effectiveness following its approval for use. Participants will receive the treatment on one of these areas, and researchers will closely monitor their experiences and results. This trial suits individuals with visible fat in these areas who haven't experienced significant weight changes or undergone recent procedures on these spots. As a Phase 4 trial, the study focuses on understanding how this FDA-approved and effective treatment can benefit more patients.
Do I need to stop my current medications for the CoolSculpting trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.
What is the safety track record for the CoolSculpting Elite System?
Research has shown that CoolSculpting Elite is generally safe and effective for reducing fat. In past studies, participants expressed high satisfaction with the results. Specifically, treatments on areas like the torso and thighs have proven both safe and effective. CoolSculpting Elite uses cryolipolysis, a method that freezes fat cells without harming the skin.
The system includes safety features that monitor skin temperature to protect the tissue. It is also FDA-cleared for treating visible fat in areas like under the chin. While most people do not experience serious side effects, some might notice temporary redness, swelling, or numbness in the treated area. These effects usually resolve on their own. Overall, the treatment has a strong safety record, making it a reliable choice for non-invasive fat reduction.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the CoolSculpting Elite System for fat reduction because it offers a non-invasive alternative to traditional options like liposuction. Unlike surgical procedures that require incisions and recovery time, CoolSculpting uses controlled cooling to freeze and eliminate fat cells, allowing for a more comfortable and convenient experience. This treatment is applied to specific areas such as the submental region, inner thighs, and back/bra area, making it versatile for targeting stubborn fat pockets. Additionally, it provides a safer option with minimal downtime, which is why it's generating quite a buzz in the world of fat reduction.
What is the effectiveness track record for CoolSculpting Elite in reducing fat in specific body areas?
Research has shown that CoolSculpting Elite effectively reduces fat in specific areas. In this trial, participants will receive applications of the CoolSculpting Elite System in various body areas. Studies have found that in the area under the chin, patients can expect a 20-25% reduction in fat. Similar results occur in the inner thighs, with up to 25% of fat cells removed. In the back or bra area, the treatment also reduces fat by 20-25%. Many patients report satisfaction with the results. Overall, CoolSculpting Elite is a proven method for reducing fat without surgery.26789
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for individuals seeking non-invasive fat reduction in specific areas: under the chin, inner thighs, and back/bra regions. Participants should be looking for cosmetic improvements and willing to undergo CoolSculpting treatments with the Elite System.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive applications of the CoolSculpting Elite System in the submental, inner thigh, and back/bra areas
Follow-up
Participants are monitored for safety and effectiveness after treatment, including collection of standardized photos and satisfaction questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- CoolSculpting Elite System
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois