NCT07810231 Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
| NCT ID | NCT07810231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Capsular Contracture of Breast Implant |
| 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 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.
Eligibility Criteria
Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol. * Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination. * Known implantation date or year and known pocket plane, incision route, surface texture, and volume. * Ability to complete annual clinical assessment for up to five years. * Written informed consent. Exclusion Criteria: * Baker grade III or IV contracture at cohort entry in the analyzed breast. * Reconstructive implantation after mastectomy or major trauma. * Tissue expander. * Active breast infection or open wound at enrollment. * Planned immediate implant exchange or explantation. * Missing core implant or operative data.
Contact & Investigator
juan velez, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07810231 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Capsular Contracture of Breast Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07810231 currently recruiting?
Yes, NCT07810231 is actively recruiting participants. Contact the research team at info@velezlara.com for enrollment information.
Where is the NCT07810231 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT07810231 clinical trial?
NCT07810231 is sponsored by Research Inc. The principal investigator is juan velez, MD, plastic surgery. The trial plans to enroll 3,000 participants.