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DuraSorb® in Prosthetic Breast Reconstruction

NCT04646057 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-04-18

No results posted yet for this study

Summary

This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.

Conditions

  • Breast Reconstruction

Interventions

DEVICE

DuraSorb®

Monofilament Surgical Mesh

Sponsors & Collaborators

  • Surgical Innovation Associates, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2024-06-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04646057 on ClinicalTrials.gov