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

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ClinicalTrials.gov Identifier: NCT01885572
Recruitment Status : Active, not recruiting
First Posted : June 25, 2013
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
pfm medical ag
pfm medical titanium gmbh
Information provided by (Responsible Party):
Pfm Medical Mepro Gmbh

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Breast Reconstruction After Mastectomy Device: TiLOOP Bra Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 267 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : November 2013
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

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Arms and Interventions
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Arm Intervention/treatment
TiLOOP Bra
Treatment with TiLOOP Bra
 Device: TiLOOP Bra
Titaniferously coated polypropylene mesh


Outcome Measures
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Primary Outcome Measures :
  1. PRO [ Time Frame: 12 months after breast reconstruction ]
    Measurement of the Patient Reported Outcome (PRO).


Secondary Outcome Measures :
  1. PRO [ Time Frame: 6 and 24 months after breast reconstruction ]
    Measurement of the Patient Reported Outcome

  2. Complication Rate [ Time Frame: after 6, 12 and 24 months ]
    Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.

  3. Cosmetic Success [ Time Frame: 6, 12 and 24 months after breast reconstruction ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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 70 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
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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): NCT01885572


Locations
Germany
Charite Campus Mitte and Benjamin Franklin
Berlin, Germany, 10117
St. Gertrauden Krankenhaus
Berlin, Germany, 10713
Vivantes Kliniken am Urban
Berlin, Germany, 10967
Helios Kliniken
Berlin, Germany, 13125
Klinik für Frauenheilkunde und Geburtshilfe der Universität
Cologne, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, Germany, 60431
St. Elisabeth Krankenhaus
Koeln, Germany, 50935
Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde
Lübeck, Germany
Technische Universität
Muenchen, Germany, 81675
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
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Responsible Party: Pfm Medical Mepro Gmbh
ClinicalTrials.gov Identifier: NCT01885572     History of Changes
Other Study ID Numbers: pfm 12k001 TiLOOP Bra
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

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