Trial Outcomes & Findings for Pilot Study on the Submental Area (NCT NCT01859091)

Last Updated: 2025-08-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

8-weeks post treatment

Results posted on

2025-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Fat Reduction The Zeltiq System: Non-invasive cooling applied to the treatment area with a defined cooling rate and duration.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study on the Submental Area

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fat Reduction n=14 Participants The Zeltiq System: Non-invasive cooling applied to the treatment area with a defined cooling rate and duration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.1 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8-weeks post treatment

Population: All enrolled subjects (Fat Reduction group) who received treatment.

Outcome measures

Outcome measures
Measure	Fat Reduction n=14 Participants The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) Device and/ or Procedure Related AEs	0 participants
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) SADEs	0 participants

SECONDARY outcome

Timeframe: Baseline, 8-weeks post treatment

Population: Per Protocol population consisted of participants who received treatment and had ultrasound data collected at the 8-weeks post treatment time point.

Change in the fat layer thickness will be calculated by comparison of pre-treatment and 8-week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.

Outcome measures

Outcome measures
Measure	Fat Reduction n=13 Participants The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound	0.5 mm Interval 0.14 to 0.85

SECONDARY outcome

Timeframe: 8-weeks post treatment

Population: Per Protocol population consisted of participants who received treatment, had a weight change of no more than 10 pounds, and did not become pregnant at the time the 8-week assessments were performed compared to the weight obtained at the first treatment visit.

Photographs of the treatment areas taken at baseline and 8-weeks after final treatment were assessed for visible changes in contour in the treated areas. Pre- and post-treatment photograph pairs were randomized and reviewed by a blinded reviewer panel of 4 reviewers.

Outcome measures

Outcome measures
Measure	Fat Reduction n=56 Photograph Pair Reviews The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)	23 Number of correct photo pair reviews

Adverse Events

Fat Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sally Hallas, RN, Director Clinical Development - Body Contouring

Zeltiq Aesthetics

Phone: 209-294-5571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place