FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction (SHAPE)

MTF Biologics

Status

Enrolling

Conditions

Implant Based Breast Reconstruction

Treatments

Other: No intervention

Device: FlexHD® Pliable

Study type

Interventional

Funder types

Other

Identifiers

NCT06797258

MTF 2024-10-IDE

Details and patient eligibility

About

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique

Enrollment

259 estimated patients

Sex

Female

Ages

22+ years old

Volunteers

No Healthy Volunteers

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