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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레지스트리 요약

진행 상태
모집중 (RECRUITING)
질환/조건
Capsular Contracture of Breast Implant
시험 유형
관찰 연구 (OBSERVATIONAL)
중재 유형
의료기기, 진단 검사
개입·치료
Breast Implant Exposure, Standardized Capsular Contracture Assessment
Lead Sponsor
Research Inc (산업계)

캐시 시각: 2026-09-10 07:20:42

ClinicalTrials.gov에서 보기

요약

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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