NCT06797258 · Musculoskeletal Transplant Foundation
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
(SHAPE)
What this study is about
forward-looking, multi-center, single-treatment group$1 clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
View original scientific description
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
Interventions
DEVICE
FlexHD® Pliable
Acellular Dermal Matrix
OTHER
No intervention
Historical Control Arm
Primary outcome measures
Frequency of major complication
Time frame: 12 months
Complications that require additional hospitalization or reoperation
Frequency of reconstructive failure
Time frame: 12 months
Removal/explantation of the breast implant
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion criteria
- 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
Where
- Fort Worth, Texas
Collaborators
MCRA (an IQVIA business), Bruder Consulting International, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2025 · Source of record for eligibility and locations