Clinical Trial Search

Primary: Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) — 37.3 percentage of projection vs baseline

Primary: Volume — 0.576; 0.621 milliliters

Primary: Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale — 2 Participants

Primary: Postoperative Duration of Drain Placements — 9.2; 10.8 days — p=0.15

Primary: Percent Correct on the Knowledge Measure (Objective Knowledge Score) — 84.6; 59.7 percentage of answers correct

Primary: Breast Q Augmentation Module — 494.5; 503.4; 420 units on a scale

Primary: Facial Volume Score — 1.8; 2.2; 2.2; 2.6 units on a scale

Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants

Primary: Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M — 1.09; 1.22; 1.3; 1.87 score on a scale

Primary: Volume Restoration — 33 Participants

Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts

Primary: Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale — 8.8 Scores on a Scale

Primary: Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months — 9.4 units on a scale

Primary: Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 — 49 Participants

Primary: Decision Self-efficacy Scale — 5.7; 5.1 units on a scale

Primary: Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. — 11.4; 7.4; 6.5 milliliters

Primary: Mean Change in Post-operative Remucosalization at the Donor Site — 47.8; 37.8; 49.7; 43.5 percentage of remucosalization

Primary: Median Time Between Surgery Date and Start Date Compression. — 17; 19 day — p=>0.1574

Primary: Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix — 0; 82.8; 17.2; 0 percentage of breasts

Primary: Visual Analog Scale (VAS) — 7.47; 7.97 units on a scale

Primary: Success Rate — 65.4 percentage of participants

Primary: BreastQ Quality of Life and Satisfaction Questionnaire — 65.32; 67.07 score on a scale — p=0.05

Primary: Pain Score Measured by Visual Analog Scale — 3.48; 1.67 units on a scale — p=<0.01

Primary: Participants Who Received TiLOOP Mesh Reconstruction — 207 Patients with TiLOOP mesh reconstruction

Primary: Operative Time — 8.2; 6.9 hours

Primary: 2-point Discrimination Test — 7.5 mm

Primary: Knowledge as Measured by Decision Quality Instrument — 66.7; 66.7 score on a scale — p=0.801

Primary: Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy — 63.9; 60.8; 29.9; 40.0 percentage of original preop perfusion

Primary: Incidence of Treatment Area Healing — 30; 34 Treatment Areas — p=.005

Primary: Disease-free Survival at 2 Years — 111 Participants