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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744013
Recruitment Status : Enrolling by invitation
First Posted : November 16, 2018
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mammoplasty Device: Fortiva® 1mm Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: post market prospective, multi-center study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : March 30, 2023

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Perforated
Fortiva® 1mm perforated ADM
 Device: Fortiva® 1mm
Post mastectomy immediate reconstruction
Active Comparator: Non-perforated
Fortiva® 1mm non-perforated ADM
 Device: Fortiva® 1mm
Post mastectomy immediate reconstruction


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Fortiva® tissue matrix [ Time Frame: 24 months ]
    Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.

  2. Performance of Fortiva® tissue matrix [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744013


Locations
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Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, Germany, 60431
Frankfurt University Hospital
Frankfurt am Main, Germany, 60590
University Hospital Technical University, Munich
München, Germany, 81664
University Hospital, Ulm
Ulm, Germany, 89081
United Kingdom
Guy's Hospital
London, United Kingdom, SE1 9RT
Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
RTI Surgical
More Information
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Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT03744013    
Other Study ID Numbers: CL1104
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No