Recruiting NCT06797258
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FlexHD® Pliable, No intervention.
- Who it may be relevant to
- Registry conditions: Implant Based Breast Reconstruction. Basic parameters: from 22 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction
Overview
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]
- Frequency of reconstructive failure [Time frame: 12 months]
Secondary outcome measures (3)
- Change in patient reported outcomes [Time frame: 12 months]
- Pain [Time frame: 12 months]
- Adverse events [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Jonathan Heistein, MD Plastic & Reconstructive Surgery — Fort Worth
Identifiers
NCT: NCT06797258 · MTF 2024-10-IDE