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RESEARCH PRODUCT
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients
Assumpció Pérez-benaventeAssumpció Pérez-benaventeAlicia HernándezAntoni LluecaXavier Matias-guiuJaime SiegristAntonio Gil-morenoAntonio Gil-morenoJavier De SantiagoPablo Padilla-iserteSantiago DomingoMelchor Carbonell-sociasMelchor Carbonell-sociasVíctor LagoBerta Díaz-feijooBerta Díaz-feijooJuan GilabertMiguel AbalEfigenia AriasAureli TornéJose Luis Sánchez-iglesiasJose Luis Sánchez-iglesiasAna VilarLorena Alonso-alconadaAnca ChipirliuMaria SantacanaRafael López-lópezVictoria Sampayosubject
0301 basic medicineOncologyAdultmedicine.medical_specialtymedicine.medical_treatmentPerformanceDiseaseCarcinoma Ovarian Epithelial03 medical and health sciences0302 clinical medicineInternal medicinemedicineHumansCytoreductive surgeryProspective StudiesRadical surgeryNeoplasm MetastasisAdverse effectLaparoscopyPeritoneal NeoplasmsAgedOvarian NeoplasmsChemotherapymedicine.diagnostic_testbusiness.industryM-Trap deviceObstetrics and GynecologyCytoreduction Surgical ProceduresMiddle AgedDebulkingmedicine.diseaseSerous fluid030104 developmental biologyTreatment OutcomeOncologySpain030220 oncology & carcinogenesisAdvanced ovarian cancerFemaleNeoplasm Recurrence LocalRecurrent ovarian cancerSafetyOvarian cancerbusinessPeritoneal carcinomatosisdescription
Objective. Despite radical surgery and chemotherapy, most patients with ovarian cancer die due to disease progression. M-Trap is an implantable medical device designed to capture peritoneal disseminated tumor cells with the aim to focalize the disease. This trial analyzed the safety and performance of the device. Methods. This first-in-human prospective, multi-center, non-blinded, single-arm study enrolled 23 women with high-grade serous advanced ovarian cancer. After primary or interval debulking surgery, 3 M-Trap devices were placed in the peritoneum of the abdominal cavity. 18-months post-implantation or at disease progression, devices were initially removed by laparoscopy. The primary safety endpoint was freedom from device and procedure-related major adverse events (MAEs) through 6-months post-implantation compared to an historical control. The primary performance endpoint was histopathologic evidence of tumor cells capture. Results. Only one major adverse event was attributable to the device. 18 women were free of device and pro-cedure related MAEs (78.3%). However, the primary safety endpoint was not achieved (p = 0.131), primarily at-tributable to the greater surgical complexity of the M-Trap patient population. 62% of recurrent patients demonstrated tumor cell capture in at least one device with a minimal tumor cell infiltration. No other long-term device-related adverse events were reported. The secondary performance endpoint demonstrated a lack of disease focalization. Conclusions. The M-Trap technology failed to meet its primary safety objective, although when adjusted for surgical complexity, the study approved it. Likewise, the devices did not demonstrate the anticipated benefits in terms of tumor cell capture and disease focalization in recurrent ovarian cancer. (c) 2021 Elsevier Inc. All rights reserved.
year | journal | country | edition | language |
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2021-01-01 |