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Ensaio clínico

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

NCT: NCT07810231 · RECRUITING

ID NCTNCT07810231
EstadoRECRUITING
Data de início2014-01-12
Conclusão2026-12-15
SponsorResearch Inc (INDUSTRY)
First posted
Last updated

Resumo breve

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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