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Multicenter Study
. 2021 Jun;161(3):681-686.
doi: 10.1016/j.ygyno.2021.03.022. Epub 2021 Mar 29.

M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients

Antonio Gil-Moreno  1 , Lorena Alonso-Alconada  2 , Berta Díaz-Feijoo  3 , Santiago Domingo  4 , Ana Vilar  5 , Alicia Hernández  6 , Juan Gilabert  7 , Antoni Llueca  8 , Aureli Torné  9 , Javier de Santiago  10 , Melchor Carbonell-Socias  3 , Víctor Lago  4 , Efigenia Arias  5 , Victoria Sampayo  5 , Jaime Siegrist  6 , Anca Chipirliu  7 , Jose Luis Sánchez-Iglesias  3 , Assumpció Pérez-Benavente  3 , Pablo Padilla-Iserte  4 , Maria Santacana  11 , Xavier Matias-Guiu  11 , Miguel Abal  12 , Rafael Lopez-Lopez  13
Affiliations
Free article
Multicenter Study

M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients

Antonio Gil-Moreno et al. Gynecol Oncol. 2021 Jun.
Free article

Abstract

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.

Keywords: Advanced ovarian cancer; Cytoreductive surgery; M-Trap device; Performance; Peritoneal carcinomatosis; Recurrent ovarian cancer; Safety.

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