NCT03744013

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2024

Completed
Last Updated

May 2, 2024

Status Verified

May 1, 2024

Enrollment Period

4.7 years

First QC Date

November 14, 2018

Last Update Submit

May 1, 2024

Conditions

Mammoplasty

Outcome Measures

Primary Outcomes (2)

  • Safety of Fortiva® tissue matrix

    Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.

    24 months

  • Performance of Fortiva® tissue matrix

    • 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.

    24 months

Study Arms (2)

Perforated

ACTIVE COMPARATOR

Fortiva® 1mm perforated ADM

Device: Fortiva® 1mm

Non-perforated

ACTIVE COMPARATOR

Fortiva® 1mm non-perforated ADM

Device: Fortiva® 1mm

Interventions

Fortiva® 1mmDEVICE

Post mastectomy immediate reconstruction

Non-perforatedPerforated

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Agaplesion Markus Krankenhaus

Frankfurt am Main, 60431, Germany

Location

Frankfurt University Hospital

Frankfurt am Main, 60590, Germany

Location

University Hospital Technical University, Munich

München, 81664, Germany

Location

University Hospital, Ulm

Ulm, 89081, Germany

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: post market prospective, multi-center study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

May 7, 2019

Primary Completion

January 9, 2024

Study Completion

January 9, 2024

Last Updated

May 2, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)DE(4)