Pilot Study on the Submental Area

NCT01859091 | Completed Results

• 1 other identifier: ZA13-004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.

Conditions

Body Fat Disorder

Keywords

Lipolysis; Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)

  An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.

  8-weeks post treatment

Secondary Outcomes (2)

• Change in the Fat Layer of the Treated Area as Measured by Ultrasound

  Baseline, 8-weeks post treatment

• Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)

  8-weeks post treatment

Study Arms (1)

Fat Reduction

EXPERIMENTAL

Device: The Zeltiq System

Interventions

The Zeltiq System DEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Also known as: Cryolipolysis, Lipolysis

Fat Reduction

Eligibility Criteria

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

You may qualify if:

• Male or female subjects \> 18 years of age and \< 65 years of age.
• Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
• No weight change exceeding 10 pounds in the preceding month.
• Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
• Subject has signed a written informed consent form.

You may not qualify if:

• Skin laxity in the neck or chin area for which reduction in submental fat may.
• Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
• Enlargement on the anterior neck that may prevent the proper placement of the applicator.
• Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
• Botulinum toxin injections within the neck or chin area.
• History of a fat reduction procedure in the area of intended treatment.
• History of prior surgery in the area of intended treatment.
• Current dental infection.
• Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• Impaired skin sensation or thermal sensitivity in the intended treatment area.
• Open or infected wounds in the intended treatment area.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Innovation Research Center

Pleasanton, California, 94588, United States

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Results Point of Contact

• Title: Sally Hallas, RN, Director Clinical Development - Body Contouring
• Organization: Zeltiq Aesthetics

sally.hallas@abbvie.com

209-294-5571

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 21, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Locations

US (1)