Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery (TIGR-Matrix)

May 6, 2026 updated by: AWOgyn

National, Prospective, Multicentre Post Market Surveillance Study on "Patient Reported Outcome" of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR® Matrix

The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Halle, Germany, 06110
        • Recruiting
        • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
        • Contact:
        • Principal Investigator:
          • Tilmann Lantzsch, Dr. med.
    • Baden-Wurttemberg
      • Weinheim, Baden-Wurttemberg, Germany, 69469
        • Active, not recruiting
        • GRN-Klinik Weinheim
    • Bavaria
      • München, Bavaria, Germany, 80337
        • Recruiting
        • Klinik und Poliklinik für Frauenheilkunde Technische Universität München
        • Contact:
        • Principal Investigator:
          • Evelyn Klein, Dr. med.
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60431
        • Recruiting
        • Agaplesion Markus Krankenhaus Frankfurt
        • Contact:
        • Principal Investigator:
          • Katharina Kelling, Dr. med.
    • North Rhine-Westphalia
      • Wesel, North Rhine-Westphalia, Germany, 46485
        • Recruiting
        • Evangelisches Krankenhaus Wesel
        • Contact:
        • Principal Investigator:
          • Daniela Rezek, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who will undergo breast prepectoral implant-based breast reconstructive surgery

Description

Inclusion Criteria:

  • Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation
  • The health of women must comply with ECOG performance status 0-2
  • The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment
  • Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
  • Patient information has been handed out and subject signed informed consent
  • Participant has attained full age of 18 years

Exclusion Criteria:

  • Pregnancy or breast-feeding patients
  • Known intolerance to the material, mesh-implants under investigation
  • Metastatic breast cancer (with a life expectancy < 5 years)
  • Medicinal dis-regulated diabetes
  • Inadequate bone marrow function with neutrophil granulocytes<1500 and blood plates < 100.000/µl
  • Lack or withdrawn of written patients informed consent
  • Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol
  • Participant is institutionalized by court or official order (MPDG §27)
  • Participation in another surgical clinical investigation that influence the surgical technique or outcome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life 12 months after surgery (BREAST-Q)
Time Frame: 12 months after surgery
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)
Time Frame: 6, 24, 36 months after surgery
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
6, 24, 36 months after surgery
Complication rate of specific complications
Time Frame: minimum of 3 years and a maximum of 5 years after surgery

Complication rate of:

  • Seroma-Volume (Sum of fluid-volume during the drainage-time)
  • Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up
  • Reconstructive failure (defined as unplanned implant loss)
minimum of 3 years and a maximum of 5 years after surgery
Days with drain(s)
Time Frame: during hospital stay after surgery
The number of days between placement of drain system and removal of the drain
during hospital stay after surgery
Days of hospital stay
Time Frame: surgery to discharge from hospital
The number of days the participant spend in hospital after surgery
surgery to discharge from hospital
Cosmetic outcome
Time Frame: 6, 12, 24 ,36 month after surgery
Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician
6, 12, 24 ,36 month after surgery
Rate of unplanned conversion operations
Time Frame: minimum of 3 years and a maximum of 5 years after surgery
Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction)
minimum of 3 years and a maximum of 5 years after surgery
Complication rate
Time Frame: minimum of 3 years and a maximum of 5 years after surgery
The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)
minimum of 3 years and a maximum of 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AWOgyn

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Esculape GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marc Thill, Prof., AWOgyn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AWO-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings