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| ID | Type | Description | Link |
|---|---|---|---|
| 104796386 | Other Identifier | Bundesamt für Sicherheit im Gesundheitswesen BASG |
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Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.
Requested answers:
Breast cancer-diagnosed patients and patients undergoing prophylactic mastectomy will undergo unior bilateral tissue expander breast reconstruction. Participants will be screened and only after the eligibility is confirmed, the patients will be included and randomized in either receiving prepectoral uni- or bilateral MRI-conditional: Arm 1 or Arm 2 TE. Within the first operation patients will receive an expander (=inflatable silicone implant) to increase the amount of tissue available for breast reconstruction. The expander is positioned in the subcutaneous plane combined with or without a GalaFLEX™ matrix, a biologically derived 2D scaffold.
The suture is removed (visit 2) and the expander is stepwise filled in 2-3 visits (visit 3 and 4, an optional visit 4b might be necessary).
The two study arms are further divided in subjects with adjuvant radiotherapy (collective I) or without adjuvant radiotherapy (collective II) according standard of care.
The decision regarding the adjuvant radiotherapy following breast implantation is be made by the surgeon and the radiation oncologist before inclusion into the study. If subjects from collective II need an adjuvant radiotherapy based on interdisciplinary tumorboard decision after OP 1 (pretherapeutical nodal + patients and/or on definitive histological findings in mastectomy specimens/axillary lymphnodes), subjects will switch from collective II to collective I.
After 6 months, the expander is removed and a permanent silicone breast implant is placed (exchange expander to definitive implant or autologous tissue; OP 2). Two clinical follow-up visits will be scheduled 12 and 24 months after the second operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Motiva Flora® tissue expander | Experimental | Within the first operation (OP 1, visit 1), patients will receive an expander (=inflatable silicone implant) to increase the amount of tissue available for breast reconstruction. The expander is positioned in the subcutaneous plane combined with or without a GalaFLEX™ matrix, a biologically derived 2D scaffold, with native tissue ingrowth through its poly-4-hydroxybutyrate (P4HB)-based open-pore monofilament structure, providing immediate supplemental soft tissue repair support and long-term strength. Matrix/Scaffold are only needed for fixation of Mentor expanders, not for Motiva Flora expander. The Motiva Flora® Tissue Expanders also includes two fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket. |
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| Arm 2: Mentor® SILTEX™ BECKER™ | Experimental | In case of MENTOR™ SILTEX™ BECKER™ expanders, the MENTOR™ TRUE-LOCK™ Connector is designed to join the preinserted or preattached fill tube of the Mentor expander to the injection dome. Once the MENTOR™ SILTEX™ BECKER™ expanders are expanded to the desired volume, the fill tube and injection dome will not be removed through a small incision under local anesthetic, instead the fill tube and injection dome are kept in situ, until the expander is replaced with the definitive implant. Therefore no additional operation is needed and the risk for infections will be reduced. |
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| Collective I: subjects with adjuvant radiotherapy - | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy | Radiation | Patients who are scheduled for tissue expander-based breast reconstruction will be randomized in one of two expander groups (Arm 1= Motiva Flora® Tissue Expander & Arm 2 = SILTEX™ BECKER™ expander). Subjects, who are routinely scheduled for radiotherapy (collective I) will subsequently undergo two additional visits. Subjects without scheduled radiotherapy (collective II), will continue without additional visits - unless they need to change their collective for therapeutic reasons. Assesments:
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use. | Breast magnetic resonance imaging (MRI) will be routinely performed before surgery (diagnostic MRI, OP1 - Baseline). MRI and Ultrasound will be study specific performed before radiotherapy at Screening, Visit 5 (pre RT Coll 1, ), Visit7 (pre OP2 Coll1) and Visit 5 (pre OP2 Coll 2). Furthermore in order to analyze skin flap thickness, seroma formation, expander and port dislocation the thickness of the capsule formed around the expanders at defined spots (12 o'clock, 3, 6 and 9 o'clock). Additionally, some patients will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer. | It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Average trial duration per subject will be: 33,5 months; Duration of follow-up-phase is 2 years (FU1-12 months; FU2-24 months). |
| Aesthetic outcome assessment by Breast Aesthetic Scale and tissue analysis | For comparative analysis of the aesthetic outcome, the applyed standardized "Breast Aesthetic scale" assessment tool by evaluating standardized preoperative and postoperative photo documentation will be used. Additionaly BIS (Body Image Scale), EORTC-QLQ-SH22, BREAST-Q are patient-reported outcome measures (PROM). Capsular tissue will be excised two times 6x2cm at OP2, if patients have Mentor expanders implanted. | It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Average trial duration per subject will be: 33,5 months; Duration of follow-up-phase is 2 years (FU1-12 months; FU2-24 months). |
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Inclusion Criteria:
Exclusion Criteria:
Only women undergo therapeutic or prophylactic uni- or bilateral, skin or nipple-sparing mastectomy with prepectoral expander-based breast reconstruction with and without adjuvant radiotherapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department | Contact | 43/512/504/82050 | dolores.wolfram@i-med.ac.at | |
| Assoc. Prof. PD. Dr. med. univ. Barbara Del-Frari Department o | Contact | 43/512/504/80899 | barbara.del-frari@tirol-kliniken.at |
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The decision regarding the adjuvant radiotherapy following breast implantation is be made by the surgeon and the radiation oncologist before inclusion into the study. Radiotherapy planning and dose constraints will be based on CT stimulation and will be scheduled according to therapeutic guidelines. The radiotherapy will be conducted routinely for three weeks (every week: 5 days with 2 days break). Pre-radiotherapy clinical examination (visit 5) and post-radiotherapy clinical examination (visit 6) is planned after the expander inflation 2.
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| Collective II: subjects without adjuvant radiotherapy | Experimental | Patients, who will not receive adjuvant radiotherapy, will not attend to visit "pre-radiotherapy clinical examination" and visit "post-radiotherapy clinical examination". For this collective II, visit 5 will be the preparation for final breast reconstruction (OP 2). But if there is a need for adjuvant radiotherapy based on interdisciplinary tumor board desicion (at Visit 1, Visit 2 or Visit 3), Subject will change from Collectove 2 to Collective 1 |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D001071 | Appointments and Schedules |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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