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NCT04255810 · ClinicalTrials.gov registry record

Systemic Symptoms: Biospecimen Analysis Study

A clinical trial of Women With Breast Implants With and Without Self-reported Systemic Symptoms and Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction, sponsored by Glicksman, Caroline, M.D..

Completed
Registry status
150
Enrollment target
1
Study location

NCT04255810 is a study of Women With Breast Implants With and Without Self-reported Systemic Symptoms and Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction that has completed, run by Glicksman, Caroline, M.D.. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04255810, a study of Women With Breast Implants With and Without Self-reported Systemic Symptoms and Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction, has completed, sponsored by Glicksman, Caroline, M.D..

COMPLETED
Registry status
150 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • PROCEDURE Surgical collection of biospecimens

Study Locations (1)

New Jersey

  • Glicksman Plastic Surgery - Sea Girt

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2019-11-01
Est. Completion 2023-12-31

Sponsor

Glicksman, Caroline, M.D.

1 total trials

What the Registry Record Tells You About NCT04255810

The ClinicalTrials.gov registry entry for NCT04255810 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glicksman, Caroline, M.D., which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Women With Breast Implants With and Without Self-reported Systemic Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Surgical collection of biospecimens is the first listed.

NCT04255810 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT04255810 about?

NCT04255810 is a clinical study titled "Systemic Symptoms: Biospecimen Analysis Study". 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 q...

What is the current status of trial NCT04255810?

This trial is currently completed. The enrollment target is 150 participants. The study started on 2019-11-01. Estimated completion is 2023-12-31.

What conditions does trial NCT04255810 study?

This clinical trial studies the following conditions: Women With Breast Implants With and Without Self-reported Systemic Symptoms, Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction.

What interventions are being tested in trial NCT04255810?

The interventions under investigation include: Surgical collection of biospecimens (PROCEDURE).

Who is sponsoring clinical trial NCT04255810?

This trial is sponsored by Glicksman, Caroline, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04255810 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.