NCT07810270 Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
| NCT ID | NCT07810270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Breast Implant Malposition |
| 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 inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be recorded. Standardized clinical and photographic assessments will identify displacement and rotation. The primary outcome is time to clinically significant implant malposition or rotation; direction, reoperation, patient-reported outcomes, and early postoperative predictors will also be analyzed.
Eligibility Criteria
Inclusion Criteria: * Female sex and age 18 years or older. * Primary or revision aesthetic breast implantation with a permanent implant. * Complete documentation of pocket plane, incision route, texture, shape, volume, laterality, and operative pocket measurements. * Standardized early postoperative baseline photography and clinical position assessment. * Ability to complete follow-up through 24 months. * Written informed consent. Exclusion Criteria: * Reconstructive implantation after mastectomy or major trauma. * Tissue expander. * Immediate major postoperative complication requiring implant removal before the position baseline can be established; these cases remain in safety reporting but not the position-risk cohort. * Missing operative or device variables. * Inability to obtain standardized photographs or position measurements. * Planned pregnancy during the first 12 months if the final protocol elects to exclude it.
Contact & Investigator
juan velez, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07810270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Implant Malposition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07810270 currently recruiting?
Yes, NCT07810270 is actively recruiting participants. Contact the research team at info@velezlara.com for enrollment information.
Where is the NCT07810270 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT07810270 clinical trial?
NCT07810270 is sponsored by Research Inc. The principal investigator is juan velez, MD, plastic surgery. The trial plans to enroll 3,000 participants.