NCT07810803 Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
| NCT ID | NCT07810803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Systemic Symptoms |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2014-01-12 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years. The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype. Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.
Eligibility Criteria
Inclusion Criteria: * Female sex and age 18 years or older. * Planning primary aesthetic breast augmentation with silicone implants or planning nonimplant aesthetic breast surgery such as mastopexy or reduction. * No prior permanent breast implant. * Completion of the full baseline systemic-symptom and psychosocial assessment before surgery. * Ability to participate in annual follow-up for five years. * Written informed consent. Exclusion Criteria: * Breast reconstruction after cancer, prophylactic mastectomy, congenital deformity, or major trauma. * Known active autoimmune, inflammatory, neurologic, endocrine, infectious, or malignant condition expected to cause major systemic symptom change, unless the final protocol intentionally includes and stratifies these conditions. * Current pregnancy or breastfeeding. * Prior permanent breast implant or tissue expander. * Inability to complete validated questionnaires in the authorized language. * Planned simultaneous major surgery expected to dominate systemic recovery beyond the prespecified postoperative window.
Contact & Investigator
juan velez, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07810803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07810803 currently recruiting?
Yes, NCT07810803 is actively recruiting participants. Contact the research team at info@velezlara.com for enrollment information.
Where is the NCT07810803 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT07810803 clinical trial?
NCT07810803 is sponsored by Research Inc. The principal investigator is juan velez, MD, plastic surgery. The trial plans to enroll 3,000 participants.