NCT07810205 Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
| NCT ID | NCT07810205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Breast Implant Rupture |
| 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 dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years. Confirmed rupture will require MRI or operative evidence. Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.
Eligibility Criteria
Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast augmentation with permanent silicone implants. * Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume. * Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm. * Ability to complete annual surveillance for up to five years. * Written informed consent. Exclusion Criteria: * Reconstructive implantation after mastectomy, congenital deformity, or major trauma. * Tissue expander or nonpermanent device. * Confirmed rupture at cohort entry for the implant under analysis. * PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling. * Missing core implant characteristics or implantation date. * Planned immediate explantation or exchange at enrollment for a reason unrelated to surveillance.
Contact & Investigator
juan velez, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07810205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Implant Rupture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07810205 currently recruiting?
Yes, NCT07810205 is actively recruiting participants. Contact the research team at info@velezlara.com for enrollment information.
Where is the NCT07810205 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT07810205 clinical trial?
NCT07810205 is sponsored by Research Inc. The principal investigator is juan velez, MD, plastic surgery. The trial plans to enroll 3,000 participants.