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FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

NCT06797258 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2025-04-02

No results posted yet for this study

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

DEVICE

FlexHD® Pliable

Acellular Dermal Matrix

OTHER

No intervention

Historical Control Arm

Sponsors & Collaborators

  • MCRA (an IQVIA business)

    collaborator UNKNOWN

  • Bruder Consulting International, LLC

    collaborator UNKNOWN

  • Musculoskeletal Transplant Foundation

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797258 on ClinicalTrials.gov