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NCT07810231

Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture

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Registry fields

Overall status: RECRUITING
Conditions: Capsular Contracture of Breast Implant
Study type: OBSERVATIONAL
Intervention type: DEVICE, DIAGNOSTIC_TEST
Interventions: Breast Implant Exposure, Standardized Capsular Contracture Assessment
Lead sponsor: Research Inc (INDUSTRY)

Cached at: 2026-09-10 07:20:42

View on ClinicalTrials.gov

Brief summary

This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture. Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years. The primary outcome is time to incident Baker grade III or IV contracture. Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.

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