30 closest matches · ranked by relevance
Body Fat Disorder
Primary: Percentage of Pre-Treatment Images Correctly Identified by Reviewers — 90.5 percentage of correct identifications
Treatment of Adipose Tissue in the Thighs
Primary: Clinical Improvement in Thigh Circumference — -1.22; -0.59 centimeter
Body Fat Disorder
Primary: Safety of the Zeltiq CoolSculpting System in the Outer Thighs — 8; 0 events
Body Fat Disorder
Primary: Safety of the Zeltiq Device — 7; 4; 12 device/procedure related AEs
Body Fat Disorder
Primary: Rate of Device- or Procedure-related Adverse Events — 1 device-or procedure-related AEs
Adiposity
Primary: Number of Participants With Adverse Events — 08; 01; 02 participants
Body Fat Disorder
Primary: Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel — 55.7 % 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
Lipolysis · Cryotherapy Effect
Primary: Change in Cross Sectional Area of Fat in Both Thighs — -420.25; -28.53 millimeters squares
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: Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh — -0.25 cm
Body Fat
Primary: Change of Thigh Circumference From Baseline — .98; .32 cm
Edematous Fibrosclerotic Panniculopathy (Cellulite)
Primary: 2-level Composite Responders for the Target Buttock — 12; 1; 202; 205 Participants — p=0.002
Cellulite
Primary: Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. — 22.22; 33.33; 44.44 Percentage of participants
Body Fat Disorder
Primary: Safety of CoolScupting in the Submental Area — 4 incidence of device- and/or procedure AE
Body Fat Disorder
Primary: The Number of Device and/or Procedure-Related Adverse Events — 12 device or procedure-related AEs
Body Fat Disorder
Primary: The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When…
Edematous Fibrosclerotic Panniculopathy (Cellulite)
Primary: 2-level Composite Responders for the Target Buttock — 16; 4; 194; 209 Participants — p=0.006
Fat Reduction
Primary: Proportion of Pre-treatment Images Correctly Identified — 128 photos — p=<0.001
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…
Body Fat Disorder
Primary: Proportion of Correctly Identified Pre-treatment Photos — 26 photos
Adipose Tissue
Primary: General Improvement in Skin Laxity of the Flank Area — 1.1; 2.1 units on a scale — p=<0.01
Edematous Fibrosclerotic Panniculopathy · Cellulite · Laxity; Skin
Primary: Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh — 85.7; 87.5…
Cellulite
Primary: Number of Subjects That Met the Individual Success Criteria — 19; 3 participants — p=<0.0001
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
Primary: Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response — 10; 0 Participants
Edematous Fibrosclerotic Panniculopathy (EFP) · Cellulite
Primary: Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 — 0; 0; 0; 0 Participants
Cellulite
Primary: Proportion of Subjects With ≥1-point Improvement on Investigator Global Aesthetic Improvement Scale (I-GAIS) at Day 90 (Buttocks) — 3; 2 Participants
Subcutaneous Adipose Tissue
Primary: Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline — -1.6; -.96; -1.4; -1.2 cm
Body Fat Disorder
Primary: Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. — 0; 0 UADEs