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A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis

NCT03744013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-05-02

No results posted yet for this study

Summary

This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.

Conditions

  • Mammoplasty

Interventions

DEVICE

Fortiva® 1mm

Post mastectomy immediate reconstruction

Sponsors & Collaborators

  • RTI Surgical

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2024-01-09
Completion
2024-01-09

Countries

  • Germany
  • United Kingdom

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 NCT03744013 on ClinicalTrials.gov