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Systemic Symptoms: Biospecimen Analysis Study (BII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04255810
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
The Aesthetic Surgery Education & Research Foundation
Information provided by (Responsible Party):
Caroline Glicksman, MD and Patricia McGuire, MD, The Aesthetic Surgery Education & Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment
Women With Breast Implants With and Without Self-reported Systemic Symptoms Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction Procedure: Surgical collection of biospecimens

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.
Study Design
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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic Symptoms: Biospecimen Analysis Study
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort
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
Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort
Women undergoing elective mastopexy (breast lift)
Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support


Outcome Measures
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Primary Outcome Measures :
  1. Change in self-reported systemic symptoms [ Time Frame: 3-6 weeks and 6 months and 1 year ]
    Change in self-reported symptoms on PROMIS (NIH) questionnaires


Biospecimen Retention:   Samples With DNA
Systemic blood, breast implant capsule tissue

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.
Criteria

Inclusion Criteria:

Consecutive patients who present to investigator surgeon for:

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

Exclusion Criteria:

  1. Subject lives more than three hours away from the investigator surgeon;
  2. Previous breast reconstruction for cancer;
  3. Active malignancy anywhere else in the body;
  4. Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
  5. History of radiation to the breast;
  6. Currently on anti-estrogen therapy; or
  7. HIV positive.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255810


Locations
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United States, New Jersey
Glicksman Plastic Surgery
Sea Girt, New Jersey, United States, 08750
Sponsors and Collaborators
Glicksman, Caroline, M.D.
The Aesthetic Surgery Education & Research Foundation
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Caroline Glicksman, MD and Patricia McGuire, MD, Principle Investigators, The Aesthetic Surgery Education & Research Foundation
ClinicalTrials.gov Identifier: NCT04255810    
Other Study ID Numbers: ASERF-BII Study
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anticipated completion of biospecimen and qualitative data collection in 2022, with publication in the Aesthetic Surgery Journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No