FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Musculoskeletal Transplant Foundation
Study ID
NCT06797258
Status
Recruiting
Apply to this trial

Conditions

  • Implant Based Breast Reconstruction

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FlexHD® Pliable — DEVICE
    Acellular Dermal Matrix
  • No intervention — OTHER
    Historical Control Arm

Study Details

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

Key Dates

Start date
Mar 26, 2025
Status verified
Mar 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
259 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    FlexHD® Pliable

Primary Outcome Measure

Frequency of major complication [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jonathan Heistein, MD Plastic & Reconstructive SurgeryFort WorthTexas76092
Office
(817) 820-0000

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Jonathan Heistein, MD Plastic & Reconstructive Surgery· Fort Worth, TX

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