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Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat Reduction | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Zeltiq System | Device | Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel | Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound | Baseline, Week 16 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Director Clinical Development - Body Contouring | Zeltiq Aesthetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovation Research Center | Pleasanton | California | 94588 | United States |
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All participants who consented to participate in the study underwent a screening period of 90 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | The ZELTIQ System | Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population included all participants who received the study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | The ZELTIQ System | Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel | Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. | Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Number | 95% Confidence Interval | % of images identified correctly | Baseline, Week 16 | images | images |
|
From date of first treatment up to Week 16
Safety Population included all participants who received the study treatment, with available safety evaluation after the treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The ZELTIQ System | Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sally Hallas, RN, Director Clinical Development - Body Contouring | Zeltiq Aesthetics | 209-294-5571 | sally.hallas@abbvie.com |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| The ZELTIQ System |
Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0. |
|
|
| Secondary | Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound | Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline, Week 16 |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 5 |
| 19 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stool impaction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Common Cold/Respiratory Infection | General disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Nasal congestion | General disorders | Non-systematic Assessment |
|
| Sore throat | General disorders | Non-systematic Assessment |
|
| Firmness or discrete nodules within the treatment area | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Numbness, tingling, burning lasting longer than 8 weeks | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Zeltiq requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Zeltiq requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Zeltiq needs to secure patent or proprietary protection.
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |