Clinical trial NCT02941146: DualSculpting the Abdomen Using CoolSculpting
Official title: DualSculpting the Abdomen Using CoolSculpting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.

Detailed description: The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.

Eligibility criteria: Inclusion Criteria

1. Male or female subjects \>22 years of age and \< 65 years of age.
2. Subject who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus applicator.
3. No weight change exceeding 5% of body weight in the preceding month.
4. Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
5. Subject has read and signed the study written informed consent form.

Exclusion Criteria

1. Subject has had a surgical procedure(s) in the area of intended treatmentSubject has had a surgical procedure(s) in the area of intended treatment.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
4. 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.
5. Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
6. 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.
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 is taking or has taken diet pills or supplements within the past month.
9. 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).
10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
11. Subject is pregnant or intending to become pregnant during the study period
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject has a history of hernia in the areas to be treated.
14. Subject is unable or unwilling to comply with the study requirements.
15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
16. 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 Correctly Identified Photos by Blinded Reviewers
timeFrame: Baseline to 12 weeks post-treatment
measure: Safety of the Zeltiq Device
timeFrame: 12 week post-treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 12 weeks post-treatment
Other outcomes:
Locations:
city: Ardmore
country: United States
facility: Main Line Center for Laser Surgery
state: Pennsylvania
Study officials:
References: