30 closest matches · ranked by relevance
Body Contouring
Primary: Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. — 21; 2 participants
Body Fat Disorder
Primary: Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. — 0; 0 UADEs
Skin Laxity · Lipodystrophy
Primary: Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 — 49 Participants
Non-Therapeutic Body Modification
Primary: Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit — 5.1; 5.5 Participants completed Questionnaire
Body Fat Disorder
Primary: Number of Participants With Unanticipated Adverse Device Effects (UADE) — 0 Participants with UADE reported
Bariatric Surgery Candidate
Primary: Weight Changes by Kilograms — 94.3; 96.17; 96.27; 89.4 Kilo gram
Non-invasive Fat Reduction
Primary: Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection — 83.3 percentage of…
Skin Laxity · Lipodystrophy
Primary: Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale — 2 Participants
Body Fat Disorder
Primary: Percentage of Pre-Treatment Images Correctly Identified by Reviewers — 90.5 percentage of correct identifications
Fat Disorder
Primary: Change in Fat Thickness at Final Follow-up Compared to Baseline — -1.76 millimeters
Excess Abdominal Fat
Primary: Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound — -10.5 percentage change
Adipose Tissue
Primary: General Improvement in Skin Laxity of the Flank Area — 1.1; 2.1 units on a scale — p=<0.01
Body Fat Disorder
Primary: Safety of the Zeltiq CoolSculpting System in the Outer Thighs — 8; 0 events
Obesity
Primary: Fat Reduction in Treatment Zone as Measured in Inches Lost — 3.5 inch
Body Fat Disorder
Primary: Proportion of Correctly Identified Photos by Blinded Reviewers — 28 photos
Body Fat Disorder
Primary: Percentage of Arms With Correct Identification of Baseline Versus 12-week Treatment Images of the Upper Arms by at Least Two Out of Three Blinded, Independent Reviewers…
Body Fat Disorder
Primary: Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel — 75.0 % of images identified correctly
Circumference Reduction
Primary: Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements — -2.8 centimeter
Fat Reduction
Primary: Proportion of Pre-treatment Images Correctly Identified — 128 photos — p=<0.001
Circumference Reduction of Abdomen
Primary: Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline. — 89.5 CM
Body Fat Disorder
Primary: Proportion of Correctly Identified Pre-treatment Photos — 26 photos
Central Abdominal Bulging
Primary: Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response — 37; 48 Participants — p=0.397
Body Fat
Primary: Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response — 10; 0 Participants
Body Fat Disorder
Primary: Number of Unanticipated Adverse Device Effects (UADE) — 0; 0; 0; 0 events
Body Fat Disorder
Primary: Percentage of Accurately Identified Pre-treatment Photos — 33; 23; 50; 23 photos
Body Fat Disorder
Primary: Proportion of Pre-treatment Images Correctly Identified — 32 photos
Body Contouring
Primary: Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs — -3.895; -1.136 inches
Abdominal Fat
Primary: Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment — 1.9; 0 cm
Body Fat Disorder
Primary: Rate of Device- or Procedure-related Adverse Events — 1 device-or procedure-related AEs
Body Fat Disorder
Primary: Safety of the Zeltiq Device — 7; 4; 12 device/procedure related AEs