Clinical trial NCT01101997: Non-Invasive Reduction of Abdominal Fat
Official title: Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Reduction
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.

Detailed description: The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has clearly visible fat on the abdomen.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. 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.
5. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
3. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
4. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. 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.
7. 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.
8. 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.
9. Subject is taking or has taken diet pills or supplements within the past month.
10. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
11. Subject is pregnant or intending to become pregnant in the next 6 months.
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. 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.

Primary outcomes:
measure: Proportion of Pre-treatment Images Correctly Identified
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in the Fat Layer of the Treated Area as Measured by Ultrasound
timeFrame: 16 weeks
measure: Subject Satisfaction
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery of Northern California
state: California
city: Coral Gables
country: United States
facility: Flor Mayoral, M.D.
state: Florida
city: Hunt Valley
country: United States
facility: Maryland Laser, Skin and Vein Institute
state: Maryland
city: Chestnut Hill
country: United States
facility: Skin Care Physicians of Chestnut Hill
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin and Laser Specialist LLC
state: Minnesota
Study officials:
References: