M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients
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...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión aceptada para publicación |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:2445/221636 |
| Acceso en línea: | https://hdl.handle.net/2445/221636 |
| Access Level: | acceso abierto |
| Palabra clave: | Cirurgia Quimioteràpia Metàstasi Assaigs clínics Càncer d'ovari Surgery Chemotherapy Metastasis Clinical trials Ovarian cancer |
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M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patientsGil Moreno, AntonioAlonso Alconada, LorenaDíaz Feijoo, BertaDomingo, SantiagoVilar, AnaHernández, AliciaTorné Bladé, AureliGilabert Estellés, JuanLlueca, Antonide Santiago, JavierCarbonell Socias, MelchorLago, VíctorArias, EfigeniaSampayo, VictoriaChipirliu, AncaSiegrist, JaimeSantacana, MariaMatias-Guiu, Xavier, 1958-Abal Posada, MiguelPadilla Iserte, PabloSánchez Iglesias, Jose LuisPérez Benavente, AsunciónLópez López, RafaelCirurgiaQuimioteràpiaMetàstasiAssaigs clínicsCàncer d'ovariSurgeryChemotherapyMetastasisClinical trialsOvarian cancerObjective: 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 procedure related MAEs (78.3%). However, the primary safety endpoint was not achieved (p = 0.131), primarily attributable 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.Elsevier2025202520212025info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersion37 p.application/pdfhttps://hdl.handle.net/2445/221636Articles publicats en revistes (Medicina)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésVersió postprint del document publicat a: https://doi.org/10.1016/j.ygyno.2021.03.022Gynecologic Oncology, 2021, vol. 161, num.3, p. 681-686https://doi.org/10.1016/j.ygyno.2021.03.022cc-by-nc-nd (c) Elsevier, 2021http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2216362026-05-29T05:05:01Z |
| dc.title.none.fl_str_mv |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| title |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| spellingShingle |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients Gil Moreno, Antonio Cirurgia Quimioteràpia Metàstasi Assaigs clínics Càncer d'ovari Surgery Chemotherapy Metastasis Clinical trials Ovarian cancer |
| title_short |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| title_full |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| title_fullStr |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| title_full_unstemmed |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| title_sort |
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients |
| dc.creator.none.fl_str_mv |
Gil Moreno, Antonio Alonso Alconada, Lorena Díaz Feijoo, Berta Domingo, Santiago Vilar, Ana Hernández, Alicia Torné Bladé, Aureli Gilabert Estellés, Juan Llueca, Antoni de Santiago, Javier Carbonell Socias, Melchor Lago, Víctor Arias, Efigenia Sampayo, Victoria Chipirliu, Anca Siegrist, Jaime Santacana, Maria Matias-Guiu, Xavier, 1958- Abal Posada, Miguel Padilla Iserte, Pablo Sánchez Iglesias, Jose Luis Pérez Benavente, Asunción López López, Rafael |
| author |
Gil Moreno, Antonio |
| author_facet |
Gil Moreno, Antonio Alonso Alconada, Lorena Díaz Feijoo, Berta Domingo, Santiago Vilar, Ana Hernández, Alicia Torné Bladé, Aureli Gilabert Estellés, Juan Llueca, Antoni de Santiago, Javier Carbonell Socias, Melchor Lago, Víctor Arias, Efigenia Sampayo, Victoria Chipirliu, Anca Siegrist, Jaime Santacana, Maria Matias-Guiu, Xavier, 1958- Abal Posada, Miguel Padilla Iserte, Pablo Sánchez Iglesias, Jose Luis Pérez Benavente, Asunción López López, Rafael |
| author_role |
author |
| author2 |
Alonso Alconada, Lorena Díaz Feijoo, Berta Domingo, Santiago Vilar, Ana Hernández, Alicia Torné Bladé, Aureli Gilabert Estellés, Juan Llueca, Antoni de Santiago, Javier Carbonell Socias, Melchor Lago, Víctor Arias, Efigenia Sampayo, Victoria Chipirliu, Anca Siegrist, Jaime Santacana, Maria Matias-Guiu, Xavier, 1958- Abal Posada, Miguel Padilla Iserte, Pablo Sánchez Iglesias, Jose Luis Pérez Benavente, Asunción López López, Rafael |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Cirurgia Quimioteràpia Metàstasi Assaigs clínics Càncer d'ovari Surgery Chemotherapy Metastasis Clinical trials Ovarian cancer |
| topic |
Cirurgia Quimioteràpia Metàstasi Assaigs clínics Càncer d'ovari Surgery Chemotherapy Metastasis Clinical trials Ovarian cancer |
| description |
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 procedure related MAEs (78.3%). However, the primary safety endpoint was not achieved (p = 0.131), primarily attributable 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. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 2025 2025 2025 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/acceptedVersion |
| format |
article |
| status_str |
acceptedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2445/221636 |
| url |
https://hdl.handle.net/2445/221636 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Versió postprint del document publicat a: https://doi.org/10.1016/j.ygyno.2021.03.022 Gynecologic Oncology, 2021, vol. 161, num.3, p. 681-686 https://doi.org/10.1016/j.ygyno.2021.03.022 |
| dc.rights.none.fl_str_mv |
cc-by-nc-nd (c) Elsevier, 2021 http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
| rights_invalid_str_mv |
cc-by-nc-nd (c) Elsevier, 2021 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
37 p. application/pdf |
| dc.publisher.none.fl_str_mv |
Elsevier |
| publisher.none.fl_str_mv |
Elsevier |
| dc.source.none.fl_str_mv |
Articles publicats en revistes (Medicina) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| instname_str |
Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| reponame_str |
Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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15,812429 |