Molecular Mechanisms Associated With Breast Implant Complications (NCT05736354) | Clinical Trial Compass
RecruitingNot Applicable
Molecular Mechanisms Associated With Breast Implant Complications
United States1,000 participantsStarted 2021-01-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of Biofilm in Breast Tissue
Timeframe: Through study completion, an average of 1 year
2
Analysis of host-biofilm interaction mediated oxylipins from blood
Timeframe: Through study completion, an average of 1 year
3
Cytokine analysis will be performed on breast tissue
Timeframe: Through study completion, an average of 1 year
4
Analysis of host-biofilm interaction mediated oxylipins from breast tissue
Timeframe: Through study completion, an average of 1 year