30 closest matches · ranked by relevance
Surgical Incision
Primary: Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M — 1.09; 1.22; 1.3; 1.87 score on a scale
Hypomastia · Primary Breast Augmentation
Primary: Breast Q Augmentation Module — 494.5; 503.4; 420 units on a scale
Breast Cancer · LCIS · DCIS
Primary: Quality of Life as Measured by the Breast Q — 61.9; 57.6; 74.2; 64.2 score on a scale
Macromastia
Primary: Postoperative Pain — 4.47; 4.66 units on a scale — p=0.4697
Mastopexy
Primary: Number of Participants With Areolar Dilation of up to 6mm at 12 Months — 13 Participants
Lymphedema · Edema
Primary: Change in Limb Volume — -15; -202 mL
Subjects Requiring Revision Breast Augmentation Surgery
Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts
Breast Augmentation
Primary: Post Surgical Complications and Reoperation Rate During Breast Augmentation — 1.85; 1.85 percentage of participants
Recurrent Ptosis of the Breast
Primary: Nipple to Fold Measurement on Stretch — 2.3; 2.5; 1.4; 1.4 centimeters
Pain
Primary: Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. — 20; 37 participants — p=<0.0001
Efficiency of Surgical Incision Closure · Post-operative Scar
Primary: Operative Time to Closure of Final Skin Layer — 58.38; 444.76 seconds
Breast Reconstruction · Breast Cancer
Primary: Knowledge as Measured by Decision Quality Instrument — 66.7; 66.7 score on a scale — p=0.801
Breast Cancer · Breast Reconstruction · Nipple Reconstruction
Primary: Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) — 37.3 percentage of projection vs baseline
Breast Cancer
Primary: Quality of Recovery Score — 165; 169 score on a scale
Breast-Conserving Surgery
Primary: Volume Restoration — 33 Participants
Breast Cancer
Primary: Local Recurrence — 3.1 percentage of participants
Breast Augmentation · Breast Reconstruction
Primary: Reoperation Rates — 6 participants
Breast Ptosis
Primary: Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. — 11 Participants
Macromastia
Primary: Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for…
Breast Cancer
Primary: Decision Self-efficacy Scale — 5.7; 5.1 units on a scale
Breast Lift
Primary: Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) — 20.6 centimeters
Breast Reconstruction
Primary: Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months — 9.4 units on a scale
Soft Tissue Support and Repair
Primary: Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale — 8.8 Scores on a Scale
Breast Cancer
Primary: Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) — 45.4; 67.2 score on scale
Breast Cancer
Primary: Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event — 149; 82 Breasts
Breast Augmentation
Primary: Investigator Overall Satisfaction With the Device Using a 5-Point Scale — 4.6 score on a scale
Breast Augmentation · Breast Reconstruction · Breast Revision
Primary: Local Complications — 12; 7; 8; 2 Participants
Surgical Scar · Breast Augmentation · Abdominoplasty
Primary: Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement…
Breast Cancer
Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants
Breast Cancer
Primary: Percent Correct on the Knowledge Measure (Objective Knowledge Score) — 84.6; 59.7 percentage of answers correct