Trial Outcomes & Findings for Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction (NCT NCT01728857)
NCT ID: NCT01728857
Last Updated: 2025-03-19
Results Overview
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.
COMPLETED
NA
19 participants
Baseline, Week 16
2025-03-19
Participant Flow
All participants who consented to participate in the study underwent a screening period of 90 days.
Participant milestones
| Measure |
The ZELTIQ System
Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
Received at Least 1 Study Treatment
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Baseline characteristics by cohort
| Measure |
The ZELTIQ System
n=19 Participants
Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.
|
|---|---|
|
Age, Continuous
|
41.4 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint.
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.
Outcome measures
| Measure |
The ZELTIQ System
n=13 images
Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.
|
|---|---|
|
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
|
30.8 % of images identified correctly
Interval 9.1 to 61.4
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint.
Outcome measures
| Measure |
The ZELTIQ System
n=13 Participants
Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.
|
|---|---|
|
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
|
-0.14 centimeters (cm)
Standard Deviation 0.21
|
Adverse Events
The ZELTIQ System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
The ZELTIQ System
n=19 participants at risk
Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
Gastrointestinal disorders
Stool impaction
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
General disorders
Common Cold/Respiratory Infection
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
General disorders
Cough
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
General disorders
Nasal congestion
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
General disorders
Sore throat
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
Musculoskeletal and connective tissue disorders
Firmness or discrete nodules within the treatment area
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
|
Skin and subcutaneous tissue disorders
Numbness, tingling, burning lasting longer than 8 weeks
|
5.3%
1/19 • From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
|
Additional Information
Sally Hallas, RN, Director Clinical Development - Body Contouring
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee Zeltiq requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Zeltiq requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Zeltiq needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER