National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra (PRO-BRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Pfm Medical Mepro Gmbh
Sponsor:
Collaborators:
pfm medical ag
pfm medical titanium gmbh
Information provided by (Responsible Party):
Pfm Medical Mepro Gmbh
ClinicalTrials.gov Identifier:
NCT01885572
First received: May 24, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.

The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.


Condition Intervention
Breast Reconstruction After Mastectomy
Device: TiLOOP Bra

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

Resource links provided by NLM:


Further study details as provided by Pfm Medical Mepro Gmbh:

Primary Outcome Measures:
  • PRO [ Time Frame: 12 months after breast reconstruction ] [ Designated as safety issue: No ]
    Measurement of the Patient Reported Outcome (PRO).


Secondary Outcome Measures:
  • PRO [ Time Frame: 6 and 24 months after breast reconstruction ] [ Designated as safety issue: No ]
    Measurement of the Patient Reported Outcome

  • Complication Rate [ Time Frame: after 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.

  • Cosmetic Success [ Time Frame: 6, 12 and 24 months after breast reconstruction ] [ Designated as safety issue: No ]
    Cosmetic success confirming the reinforcement will be assessed by the patient and an independent professional at a photo. The questions posed are part of the validated Breast Q questionnaire.


Estimated Enrollment: 260
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TiLOOP Bra
Treatment with TiLOOP Bra
Device: TiLOOP Bra
Titaniferously coated polypropylene mesh

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria:

Clinical Criteria (reason):

  • women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant
  • women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history
  • the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0-2

Study-related inclusion criteria - Legal reasons:

  • Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
  • Patient information has been handed out and all written consents are at hand.
  • Patient is between 18 and 75 years old.

Exclusion Criteria:

Patients must be excluded if any of the following conditions exist or cannot be excluded:

Device-related exclusion criteria (contraindications):

Pathological or physical condition precluding such as:

  • Pregnancy or breast-feeding patients
  • Known intolerance to the mesh-implants under investigation.

Study-related exclusion criteria - Medical reasons:

  • metastatic breast cancer
  • medicamentous regulated diabetes with blood sugar level >250
  • inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates < 10000/µl
  • patient with known contraindication to mesh-implants or plastic-reconstructive breast operations

Study-related exclusion criteria - Legal reasons:

  • Lack of written patients informed consent.
  • Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
  • Patient is institutionalized by court or official order (MPG§20.3).
  • Participation in another operative clinical investigation.

It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885572

Contacts
Contact: Sabrina Tofall sabrina.tofall@pfmmedical.com

Locations
Germany
Helios Kliniken Not yet recruiting
Berlin, Germany, 13125
Principal Investigator: Christine Mau, Dr.         
Vivantes Kliniken am Urban Not yet recruiting
Berlin, Germany, 10967
Principal Investigator: Andree Faridi, Prof. Dr.         
St. Gertrauden Krankenhaus Not yet recruiting
Berlin, Germany, 10713
Principal Investigator: Jens-Uwe Blohmer, Prof. Dr.         
Agaplesion Markus Krankenhaus Not yet recruiting
Frankfurt am Main, Germany, 60431
Principal Investigator: Marc Thill, Dr.         
St. Elisabeth Krankenhaus Not yet recruiting
Koeln, Germany, 50935
Principal Investigator: Anette Meire, Dr.         
Technische Universität Recruiting
Muenchen, Germany, 81675
Principal Investigator: Stefan Paepke, Dr.         
Universitätsfrauenklinik Not yet recruiting
Rostock, Germany, 18057
Principal Investigator: Max Dieterich, Dr.         
Sponsors and Collaborators
Pfm Medical Mepro Gmbh
pfm medical ag
pfm medical titanium gmbh
Investigators
Principal Investigator: Stefan Paepke, MD Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany
  More Information

No publications provided

Responsible Party: Pfm Medical Mepro Gmbh
ClinicalTrials.gov Identifier: NCT01885572     History of Changes
Other Study ID Numbers: pfm 12k001 TiLOOP Bra
Study First Received: May 24, 2013
Last Updated: January 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfm Medical Mepro Gmbh:
breast reconstruction
mastectomy
mesh
breast cancer

ClinicalTrials.gov processed this record on September 16, 2014