DualSculpting the Abdomen Using CoolSculpting (DSA)

Zeltiq Aesthetics

Status: Completed

Conditions: Body Fat Disorder

Treatments: Device: The ZELTIQ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02941146

ZA16-004

Details and patient eligibility

About

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

Full description

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

Enrollment: 15 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Zeltiq Dual Sculpting Treatment Group

Experimental group

Description:

All subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen.

Treatment:

Device: The ZELTIQ System