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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: Completed study 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..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in self-reported symptoms on PROMIS (NIH) questionnaires
Conditions Studied
Interventions
- PROCEDURE Surgical collection of biospecimens
Study Locations (1)
New Jersey
- Glicksman Plastic Surgery - Sea Girt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2023-12-31 |
What the finished NCT04255810 record still lists
NCT04255810 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
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 a single indexed study location in 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.
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