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CoolSculpting in the Abdomen Using Applicator With and Without CCI

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Zeltiq Aesthetics

Status

Completed

Conditions

Body Fat Disorder

Treatments

Device: CoolSculpting Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT02787850
ZA16-002

Details and patient eligibility

About

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Full description

Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Enrollment

20 patients

Sex

All

Ages

22 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Male or female subjects >22 years of age and < 65 years of age.
  • Subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment.
  • Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
  • No weight change exceeding 5% of body weight in the preceding month.
  • 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.
  • Subject has read and signed the study written informed consent form. Exclusion Criteria
  • Subject has had a surgical procedure(s) in the area of intended treatment.
  • Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
  • Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
  • 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.
  • Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
  • 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.
  • 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 is taking or has taken diet pills or supplements within the past month.
  • 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).
  • Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
  • Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
  • Subject is lactating or has been lactating in the past 6 months.
  • Subject has a history of hernia in the areas to be treated.
  • 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.
  • Subject is prone to severe claustrophobia (during MRI scans).
  • 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

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

CoolSculpting Treatment Cohort A
Experimental group
Description:
Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes using the CoolMax applicator without the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with the Crown Cooling Insert at a second protocol-defined temperature for 45 minutes. Each half of the abdominal area will be treated once, for a total of two treatments per subject.
Treatment:
Device: CoolSculpting Treatment
CoolSculpting Treatment Cohort B
Active Comparator group
Description:
Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes using the CoolMax applicator with the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with a second protocol-defined temperature for 60 minutes with the Crown Cooling Insert. Each half of the abdominal area will be treated once, for a total of two treatments per subject.
Treatment:
Device: CoolSculpting Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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