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| Name | Class |
|---|---|
| Esculape GmbH | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIGR® Matrix | Device | bioresorbable, synthetic, surgical mesh |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life 12 months after surgery (BREAST-Q) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life 6, 24, 36 months after surgery (BREAST-Q) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women who will undergo breast prepectoral implant-based breast reconstructive surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Thill, Prof. | Contact | +49 69 95 33 22 28 | Marc.Thill@agaplesion.de |
| Name | Affiliation | Role |
|---|---|---|
| Marc Thill, Prof. | AWOgyn | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GRN-Klinik Weinheim | Active, not recruiting | Weinheim | Baden-Wurttemberg | 69469 | Germany | |
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| Complication rate |
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 |
| Complication rate of specific complications | Complication rate of:
| minimum of 3 years and a maximum of 5 years after surgery |
| Days with drain(s) | The number of days between placement of drain system and removal of the drain | during hospital stay after surgery |
| Days of hospital stay | The number of days the participant spend in hospital after surgery | surgery to discharge from hospital |
| Cosmetic outcome | 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 | 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 |
| Klinik und Poliklinik für Frauenheilkunde Technische Universität München |
| Recruiting |
| München |
| Bavaria |
| 80337 |
| Germany |
|
| Agaplesion Markus Krankenhaus Frankfurt | Recruiting | Frankfurt am Main | Hesse | 60431 | Germany |
|
| Evangelisches Krankenhaus Wesel | Recruiting | Wesel | North Rhine-Westphalia | 46485 | Germany |
|
| Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH | Recruiting | Halle | 06110 | Germany |
|