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CompletedNCT01728857TOPSUpdated Mar 19, 2025Results posted

Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

An interventional study of The Zeltiq System in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Zeltiq Aesthetics · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.

02

Conditions studied

  • Body Fat Disorder

Keywords

  • Lipolysis
  • Cryolipolysis
  • Fat Reduction
03

In context

Lipid Metabolism Disorders

180 studies on the registry are indexed under Lipid Metabolism Disorders; 33 are open to participants now.

This study's enrollment of 19 is below the median of 51 across 136 interventional studies indexed under Lipid Metabolism Disorders.

Browse Lipid Metabolism Disorders studies →

Lead sponsor

Zeltiq Aesthetics is the lead sponsor of 39 studies on the registry; none are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 29 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female subjects > 18 years of age and \< 65 years of age.
  2. Subject has clearly visible fat on intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).
  3. Subject has not had weight change exceeding 10 pounds in the preceding month.
  4. Subject with body mass index (BMI) less than 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
  6. Subject has read and signed a written informed consent form.

Exclusion criteria

Exclusion Criteria

  1. Subject presents a significant asymmetry of intended treatment areas.
  2. Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.
  3. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.
  4. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
  5. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
  6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  7. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
  8. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  9. Subject is taking or has taken diet pills or weight control supplements within the past month.
  10. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
  11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system.
  12. Subject is pregnant or intending to become pregnant in the next 5 months.
  13. Subject is lactating or has been lactating in the past 6 months.
  14. Subject has a history of hernia in the areas to be treated.
  15. Subject is unable or unwilling to comply with the study requirements.
  16. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  17. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Fat Reduction

    Device: The Zeltiq System

Interventions

  • DeviceThe Zeltiq System

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

    Also known as: Cryolipolysis, Lipolysis

06

What researchers measure

Primary outcomes

  1. Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel

    Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.

    Time frame: Baseline, Week 16

Secondary outcomes

  1. Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound

    Time frame: Baseline, Week 16

07

Results

Posted Mar 19, 2025

Participant flow

Participant flow — Overall Study
MilestoneThe ZELTIQ System
Started19
Received at least 1 study treatment19
Completed19
Not completed0

Outcome measures

PrimaryPercentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel

Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.

Time frame:
Baseline, Week 16
Reported as:
Number · % of images identified correctly
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
% of images identified correctlyThe ZELTIQ System
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel30.8 (9.1 to 61.4)
SecondaryChange From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
Time frame:
Baseline, Week 16
Reported as:
Mean · centimeters (cm)
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
centimeters (cm)The ZELTIQ System
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound-0.14 ± 0.21

Adverse events

Collected over From date of first treatment up to Week 16. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
The ZELTIQ System0/19 (0%)0/19 (0%)5/19 (26.3%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventThe ZELTIQ System
NauseaGastrointestinal disorders3/19
VomitingGastrointestinal disorders3/19
ConstipationGastrointestinal disorders1/19
DiarrheaGastrointestinal disorders1/19
Stool impactionGastrointestinal disorders1/19
Common Cold/Respiratory InfectionGeneral disorders1/19
CoughGeneral disorders1/19
Nasal congestionGeneral disorders1/19
Sore throatGeneral disorders1/19
Firmness or discrete nodules within the treatment areaMusculoskeletal and connective tissue disorders1/19

Baseline characteristics

Safety Population included all participants who received the study treatment.

Age, Continuous
Age, Continuous(years)The ZELTIQ System
Median41.4 (27.2 to 56.0)
Sex: Female, Male
Sex: Female, Male(Participants)The ZELTIQ System
Female12
Male7
Race (NIH/OMB)
Race (NIH/OMB)(Participants)The ZELTIQ System
American Indian or Alaska Native0
Asian6
Native Hawaiian or Other Pacific Islander0
Black or African American0
White11
More than one race0
Unknown or Not Reported2
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)The ZELTIQ System
Hispanic or Latino1
Not Hispanic or Latino18
08

Study locations

1 site
  • Innovation Research Center
    Pleasanton, California 94588, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01728857
Lead sponsor
Zeltiq Aesthetics
Responsible party
Sponsor
First posted
Nov 20, 2012
Start date
Nov 2012
Primary completion
Mar 10, 2014
Completion
Mar 10, 2014
Results posted
Mar 19, 2025
Last update
Mar 19, 2025

Study contacts

Director Clinical Development - Body Contouring
study director · Zeltiq Aesthetics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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