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Updated: Nov 10, 2025
Quantitation of Intra-peritoneal Ovarian Cancer Metastasis
Published on: July 18, 2016
M-TRAP: Safety and performance of metastatic tumor cell trap device in advanced ovarian cancer patients
Antonio Gil-Moreno1, Lorena Alonso-Alconada2, Berta Díaz-Feijoo1
1Department of Gynecologic Oncology, Vall d'Hebron University Hospital, Barcelona, Spain; Biomedical Research Group in Gynecology, Vall Hebron Research Institute (VHIR), Universitat Autonoma de Barcelona, CIBERONC, Barcelona, Spain.
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.
Insights
The M-Trap device, designed to capture ovarian cancer cells, showed minimal tumor cell capture and failed to focalize disease. While generally safe, it did not meet primary safety or performance objectives in advanced ovarian cancer patients.
Area of Science:
- Oncology
- Biomedical Engineering
- Surgical Innovation
Background:
- Advanced ovarian cancer often progresses despite aggressive treatments like surgery and chemotherapy.
- Disseminated tumor cells in the peritoneum contribute to disease progression.
- The M-Trap device was developed as an implantable solution to capture these cells and potentially localize the disease.
Purpose of the Study:
- To evaluate the safety and performance of the M-Trap device in patients with advanced ovarian cancer.
- To assess the device's ability to capture peritoneal disseminated tumor cells.
- To determine if the device can achieve disease focalization.
Main Methods:
- A prospective, multi-center, single-arm study involving 23 women with high-grade serous advanced ovarian cancer.
- Implantation of three M-Trap devices into the abdominal cavity after debulking surgery.
- Assessment of safety via major adverse events (MAEs) at 6 months and performance through histopathologic analysis of captured tumor cells upon device removal.
Main Results:
- The primary safety endpoint was not met (p = 0.131), with one device-related MAE, though 78.3% of patients were free of MAEs.
- Tumor cell capture was observed in 62% of recurrent patients, but with minimal infiltration.
- The device did not demonstrate disease focalization, failing the secondary performance endpoint.
Conclusions:
- The M-Trap technology did not achieve its primary safety or performance goals for tumor cell capture and disease focalization in recurrent ovarian cancer.
- While the device showed some tumor cell capture, it did not prove effective in localizing the disease.
- Further research may be needed to refine the technology or patient selection for peritoneal tumor cell capture devices.
