FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
NCT ID: NCT06797258
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
259 participants
INTERVENTIONAL
2025-03-26
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
FlexHD® Pliable
FlexHD® Pliable
Acellular Dermal Matrix
No intervention
Historical Control Arm
Interventions
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FlexHD® Pliable
Acellular Dermal Matrix
No intervention
Historical Control Arm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
FEMALE
No
Sponsors
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MCRA (an IQVIA business)
UNKNOWN
Bruder Consulting International, LLC
UNKNOWN
Musculoskeletal Transplant Foundation
OTHER
Responsible Party
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Locations
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Jonathan Heistein, MD Plastic & Reconstructive Surgery
Fort Worth, Texas, United States
Countries
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Facility Contacts
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Office
Role: primary
Other Identifiers
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MTF 2024-10-IDE
Identifier Type: -
Identifier Source: org_study_id
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