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New treatment option for Implant Based Breast Reconstruction
Official title FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
ClinicalTrials.gov ID: NCT06797258
What this study is testing
- What it's testing
- Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- Females at least 22 years of age
- Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
- Willing to provide Informed Consent
- Able to return for all required study visits
- Must read and understand English language
You likely can't join if
- Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
- Has a residual gross tumor at the intended reconstruction site
- Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
- Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the...
- Completed chemotherapy within 3 weeks prior to surgery
- Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
See the full eligibility criteria
- Females at least 22 years of age
- Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
- Willing to provide Informed Consent
- Able to return for all required study visits
- Must read and understand English language
- Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
- Has a residual gross tumor at the intended reconstruction site
- Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
- Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
- Completed chemotherapy within 3 weeks prior to surgery
- Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
- Has a Body Mass Index (BMI) \>35
- Has used nicotine products within 1 month of screening
- Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study
The study team makes the final eligibility decision.
Where it's taking place
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.