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

Sponsor
RTI Surgical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03744013
Collaborator
(none)
100
Enrollment
6
Locations
2
Arms
46.8
Anticipated Duration (Months)
16.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Fortiva® 1mm
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
post market prospective, multi-center studypost 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
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Safety of Fortiva® tissue matrix [24 months]

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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Agaplesion Markus Krankenhaus Frankfurt am Main Germany 60431
2 Frankfurt University Hospital Frankfurt am Main Germany 60590
3 University Hospital Technical University, Munich München Germany 81664
4 University Hospital, Ulm Ulm Germany 89081
5 Guy's Hospital London United Kingdom SE1 9RT
6 Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital Manchester United Kingdom M23 9LT

Sponsors and Collaborators

  • RTI Surgical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RTI Surgical
ClinicalTrials.gov Identifier:
NCT03744013
Other Study ID Numbers:
  • CL1104
First Posted:
Nov 16, 2018
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 25, 2022