NCT07810257 Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
| NCT ID | NCT07810257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Breast Implant Complication |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2014-01-12 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2014-01-12 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume. * No fissure or rupture identified by the baseline imaging algorithm. * Ability to undergo annual ultrasound and confirmatory MRI when indicated. * Written informed consent. Exclusion Criteria: * Confirmed fissure or rupture at cohort entry. * Reconstructive breast implantation or tissue expander. * Immediate planned implant removal or exchange. * Missing core implant characteristics. * MRI contraindication when MRI is required to adjudicate a suspected event. * Recalled/PIP implant if excluded by the final analytic plan.
Contact & Investigator
juan velez, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07810257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Implant Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07810257 currently recruiting?
Yes, NCT07810257 is actively recruiting participants. Contact the research team at info@velezlara.com for enrollment information.
Where is the NCT07810257 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT07810257 clinical trial?
NCT07810257 is sponsored by Research Inc. The principal investigator is juan velez, MD, plastic surgery. The trial plans to enroll 3,000 participants.