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Acellular Dermal Matrix Investigation in Breast Reconstruction

NCT06456554 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2026-04-30

No results posted yet for this study

Summary

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Conditions

  • Breast Reconstruction

Interventions

DEVICE

Acellular Dermal Matrix (Cortiva Tissue Matrix)

non-crosslinked dermis

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • RTI Surgical

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2026-12-31
Completion
2027-12-31
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 NCT06456554 on ClinicalTrials.gov