Systemic Symptoms: Biospecimen Analysis Study | NCT04255810

Studies
Systemic Symptoms: Biospecimen Analysis Study

NCT04255810

Sponsor

Glicksman, Caroline, M.D.

Status

Completed

Last Update Posted

Aug 22, 2025Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Women With Breast Implants With and Without Self-reported Systemic Symptoms
Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction

Interventions

Surgical collection of biospecimens

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Feb 3, 2020

First Submission Date that Met QC Criteria

Feb 3, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2025

Last Update Posted Date

Aug 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Caroline Glicksman, MD and Patricia McGuire, MD, Principle Investigators, The Aesthetic Surgery Education & Research FoundationPrincipal Investigator

Lead Sponsor

Glicksman, Caroline, M.D.INDIV

Collaborators

Name	Class
The Aesthetic Surgery Education & Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Detailed Description

An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. The term Breast Implant Illness or "BII" originated with several social media groups. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. Recently several studies have been designed and funded to study the role of psychological and social behavioral factors. This study has been designed to scientifically analyze biospecimens from three cohorts of age matched women in the United States. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Women with breast implants and self-reported symptoms of BII	Women undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII	Procedure: Surgical collection of biospecimens
Women with breast implants and no self-reported BII	Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII	Procedure: Surgical collection of biospecimens
Women undergoing elective mastopexy (breast lift)	Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical collection of biospecimens	Procedure	Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in self-reported systemic symptoms	Change in self-reported symptoms on PROMIS (NIH) questionnaires	3-6 weeks and 6 months and 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients who present to investigator surgeon for:

Self-reported BII requesting explantation;
Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
Genetic Female.

Exclusion Criteria:

Subject lives more than three hours away from the investigator surgeon;
Previous breast reconstruction for cancer;
Active malignancy anywhere else in the body;
Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
History of radiation to the breast;
Currently on anti-estrogen therapy; or
HIV positive.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Glicksman Plastic Surgery		Sea Girt	New Jersey	08750	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Anticipated completion of biospecimen and qualitative data collection in 2022, with publication in the Aesthetic Surgery Journal. Four peer reviewed publications in Aesthetic Surgery Journal- ASERF Biospecimen Study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided