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Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years. The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype. Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.
Trial Details
NCT Number NCT07810803
Lead Sponsor Research Inc
Conditions
(from sponsor)		 Systemic Symptoms, Breast Implant Illness, Breast Implant Complications
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov