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

National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

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.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction After Mastectomy
• Intervention / Treatment: Device: TiLOOP Bra

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Helios Kliniken
  • Berlin, Germany, 10117
    • Charite Campus Mitte and Benjamin Franklin
  • Berlin, Germany, 10713
    • St. Gertrauden Krankenhaus
  • Berlin, Germany, 10967
    • Vivantes Kliniken am Urban
  • Frankfurt am Main, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Koeln, Germany, 50935
    • St. Elisabeth Krankenhaus
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde
  • Muenchen, Germany, 81675
    • Technische Universität

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: TiLOOP Bra; Treatment with TiLOOP Bra	Device: TiLOOP Bra; Titaniferously coated polypropylene mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRO	Measurement of the Patient Reported Outcome (PRO).	12 months after breast reconstruction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRO	Measurement of the Patient Reported Outcome	6 and 24 months after breast reconstruction
Complication Rate	Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.	after 6, 12 and 24 months
Cosmetic Success	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.	6, 12 and 24 months after breast reconstruction
PRO and Complication Rate	Measurement of the Patient Reported Outcome and complication rate of all patients	48 months after breast reconstruction

Collaborators and Investigators

• Sponsor: Pfm Medical Mepro Gmbh
• Collaborators: pfm medical ag
• Investigators: Principal Investigator: Stefan Paepke, MD, Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany

Publications and helpful links

General Publications

• Thill M, Faridi A, Meire A, Gerber-Schafer C, Baumann K, Blohmer JU, Mau C, Tofall S, Nolte E, Strittmatter HJ, Ohlinger R, Paepke S. Patient reported outcome and cosmetic evaluation following implant-based breast-reconstruction with a titanized polypropylene mesh (TiLOOP(R) Bra): A prospective clinical study in 269 patients. Eur J Surg Oncol. 2020 Aug;46(8):1484-1490. doi: 10.1016/j.ejso.2020.04.009. Epub 2020 Apr 15.
• Nolte E, Klein E, Paepke S. Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result. Plast Reconstr Surg Glob Open. 2018 Sep 14;6(9):e1919. doi: 10.1097/GOX.0000000000001919. eCollection 2018 Sep.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (ESTIMATE): June 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; breast reconstruction; mastectomy; mesh
• Other Study ID Numbers: pfm 12k001 TiLOOP Bra

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No