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

Not Applicable

Completed

• Conditions: Mammoplasty
• Interventions: Device: Fortiva® 1mm

• Registration Number: NCT03744013
• Lead Sponsor: RTI Surgical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Study Start: 2019-05-07
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

Inclusion Criteria

1. Female 18 years or older
2. A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
3. Estimated life expectancy > 2 years
4. Able and willing to return for all scheduled and required study visits
5. Able to provide written informed consent for study participation
6. Able to read, understand and complete study questionnaires

Exclusion Criteria

1. Any of the conditions listed in the approved labeling as contraindicated
2. Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
3. Any patient that per the physician's judgement is not a good candidate for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-perforated	Fortiva® 1mm	Fortiva® 1mm non-perforated ADM
Perforated	Fortiva® 1mm	Fortiva® 1mm perforated ADM

Primary Outcome Measures

Name	Time	Method
Safety of Fortiva® tissue matrix	24 months	Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
Performance of Fortiva® tissue matrix	24 months	• Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey.

Trial Locations

Locations (6)

Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom

Frankfurt University Hospital; 🇩🇪 Frankfurt am Main, Germany

University Hospital Technical University, Munich; 🇩🇪 München, Germany

Agaplesion Markus Krankenhaus; 🇩🇪 Frankfurt am Main, Germany

University Hospital, Ulm; 🇩🇪 Ulm, Germany

Guy's Hospital; 🇬🇧 London, United Kingdom