NCT06797258RecruitingNot Applicable
Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction
Musculoskeletal Transplant Foundation1 site in 1 country259 target enrollmentStarted: March 26, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 259
- Locations
- 1
- Primary Endpoint
- Frequency of major complication
Study Overview
Brief Summary
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment Arm
Experimental
FlexHD® Pliable
Intervention: FlexHD® Pliable (Device)
Treatment Arm
Experimental
FlexHD® Pliable
Intervention: No intervention (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Adverse events(12 months)
- Change in patient reported outcomes(12 months)
- Pain(12 months)
Investigators
Study Sites (1)
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