Molecular Mechanisms Associated With Breast Implant Complications

ClinicalTrials.gov ID: NCT05736354

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05736354
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Indiana University; Other
Enrollment: 1,000 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 3, 2021 (Actual)
Primary completion: Jun 30, 2028 (Estimated)
Completion: Jun 30, 2028 (Estimated)
Last update posted: Jun 11, 2026

2021 – 2028

United States locations

U.S. sites: 3
U.S. states: 1
U.S. cities: 2

Facility	City	State	ZIP	Site status
IU Health North Hospital	Carmel	Indiana	46032	Recruiting
Meridian Plastic Surgeons	Carmel	Indiana	46290	Recruiting
IU Health Methodist Hospital	Indianapolis	Indiana	46202	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05736354, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 11, 2026 · Synced Nov 15, 2026