N/A
N=60
Non-Invasive Reduction of Abdominal Fat
Fat Reduction
Bottom Line
View on ClinicalTrials.gov: NCT01101997 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Proportion of Pre-treatment Images Correctly Identified — 128 photos — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Zeltiq System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zeltiq Aesthetics
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Pre-treatment Images Correctly Identified |
128 | <0.001 sig |
| SECONDARY Change in the Fat Layer of the Treated Area as Measured by Ultrasound |
-1.9 | — |
| SECONDARY Subject Satisfaction |
88; 60; 79; 50; 62; 62 | — |
Summary
This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects > 18 years of age.
- Subject has clearly visible fat on the abdomen.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Exclusion Criteria
- Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
- Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- 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.
- Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
- Subject is pregnant or intending to become pregnant in the next 6 months.
- Subject is lactating or has been lactating in the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- 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.
Data sourced from ClinicalTrials.gov (NCT01101997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.