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

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

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

Primary: Volume Restoration — 33 Participants

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

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

Primary: Success Rate — 65.4 percentage of participants

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

Primary: Quality of Life as Measured by the Breast Q — 61.9; 57.6; 74.2; 64.2 score on a scale

Primary: Quality of Recovery Score — 165; 169 score on a scale

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

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

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

Primary: Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event — 149; 82 Breasts

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

Primary: Rate of Breast Related Adverse Events — 12 Reconstructed breasts affected

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

Primary: Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant — 8; 12 Participants

Primary: Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved — 13 days

Primary: Change From Baseline in Average Pain Scores Using a Numeric Pain Intensity Scale — 2; 3 score on a scale — p=0.43

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

Primary: Local Complications — 15.0; 21.6; 11.1; 10.7 Percentage by Patient

Primary: Breast Projection — 19.8205 percentage loss of projection

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

Primary: Change in Limb Volume — -15; -202 mL

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

Primary: Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention — 6.64; 6.67; 4.62; 6.93 score on a scale

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: Local Complications — 18.9; 24.6; 28.7; 6.7 percentage by patient