NCT05736354 Molecular Mechanisms Associated With Breast Implant Complications
| NCT ID | NCT05736354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Breast Implant; Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-01-03 |
| Primary Completion | 2028-06-30 |
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 1,000 participants in total. It began in 2021-01-03 with a primary completion date of 2028-06-30.
⚠ 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
Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.
Eligibility Criteria
Inclusion Criteria for breast implant subjects: * Age greater than or equal to 18 years * Undergoing removal of breast implant * Willing and able to comply with protocol instructions Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal) * Age greater than or equal to 18 years * Undergoing breast surgery * Willing and able to comply with protocol instructions Exclusion Criteria: * Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent) * Pregnant females * Immunodeficiency (HIV/AIDS, SCID) * Currently on immunosuppressive medications * Prisoners
Contact & Investigator
Mithun Sinha, PhD.
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05736354 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Implant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05736354 currently recruiting?
Yes, NCT05736354 is actively recruiting participants. Contact the research team at mitsinha@iu.edu for enrollment information.
Where is the NCT05736354 trial being conducted?
This trial is being conducted at Carmel, United States, Carmel, United States, Indianapolis, United States.
Who is sponsoring the NCT05736354 clinical trial?
NCT05736354 is sponsored by Indiana University. The principal investigator is Mithun Sinha, PhD. at Indiana University. The trial plans to enroll 1,000 participants.