NCT06797258

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 259 (estimated)
• Sponsor: Musculoskeletal Transplant Foundation · Academic / Other
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Implant Based Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	FlexHD® Pliable	Acellular Dermal Matrix
OTHER	No intervention	Historical Control Arm

Timeline

• Start date: 2025-03-26
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-01-28
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study