Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07810257 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.
Trial Details
NCT Number NCT07810257
Lead Sponsor Research Inc
Conditions
(from sponsor)		 Breast Implant Complication, Breast Implant Shell Defect
Related terms Surgical Wound
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov