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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Reconstruction After Mastectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TiLOOP Bra

Treatment with TiLOOP Bra

Group Type OTHER

TiLOOP Bra

Intervention Type DEVICE

Titaniferously coated polypropylene mesh

Interventions

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TiLOOP Bra

Titaniferously coated polypropylene mesh

Intervention Type DEVICE

Eligibility Criteria

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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

* 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:

Pathological or physical condition precluding such as:

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

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No