National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra

Not Applicable

Completed

• Conditions: Breast Reconstruction After Mastectomy
• Interventions: Device: TiLOOP Bra

• Registration Number: NCT01885572
• Lead Sponsor: Pfm Medical Mepro Gmbh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-25
• Study Start: 2013-11
• Primary Completion: 2017-08
• Study Completion: 2021-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 267

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TiLOOP Bra	TiLOOP Bra	Treatment with TiLOOP Bra

Primary Outcome Measures

Name	Time	Method
PRO	12 months after breast reconstruction	Measurement of the Patient Reported Outcome (PRO).

Secondary Outcome Measures

Name	Time	Method
PRO and Complication Rate	48 months after breast reconstruction	Measurement of the Patient Reported Outcome and complication rate of all patients
Complication Rate	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.
Cosmetic Success	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.
PRO	6 and 24 months after breast reconstruction	Measurement of the Patient Reported Outcome

Trial Locations

Locations (8)

St. Gertrauden Krankenhaus; 🇩🇪 Berlin, Germany

Agaplesion Markus Krankenhaus; 🇩🇪 Frankfurt am Main, Germany

Vivantes Kliniken am Urban; 🇩🇪 Berlin, Germany

Charite Campus Mitte and Benjamin Franklin; 🇩🇪 Berlin, Germany

St. Elisabeth Krankenhaus; 🇩🇪 Koeln, Germany

Technische Universität; 🇩🇪 Muenchen, Germany

Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde; 🇩🇪 Lübeck, Germany

Helios Kliniken; 🇩🇪 Berlin, Germany