Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.

Official Title
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Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Conditions
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Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV

Intervention / Treatment
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* Device: M-Trap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a female ≥18 years old. Presents with a diagnosis of Stage IIIC ovarian cancer. Presents with high-grade serous carcinoma. Has one of the following: Visible residual tumor ≤1 cm after primary tumor debulking surgery. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery. ECOG performance status of 0 or 1. Is willing to comply with required follow-up study visits. Is willing and able to provide written informed consent. Exclusion Criteria: Has a life expectancy of <3 months. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating. Will be receiving intraperitoneal chemotherapy. Has undergone prior treatment with abdominal and/or pelvic radiotherapy. Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Presence of central nervous system or cerebral metastases. Recurrent ovarian cancer. Complete resection with no residual tumor after primary tumor debulking surgery. Suboptimal resection with >1 cm residual tumor after primary or interval tumor debulking surgery. Is simultaneously enrolled in another investigational study. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer. Has a known hypersensitivity to carboplatin or paclitaxel. Is concurrently using other antineoplastic agents.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center, non-blinded, single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-Trap<br> | Device: M-Trap<br>* Device(s) will be surgically implanted in the peritoneal cavity. Up to three (3) M-Trap devices will be surgically implanted via laparotomy in the right and left paracolic (pelvic) gutters and behind segment 6 of the liver within the peritoneal cavity of the patient at the time of surgical resection. Patients will receive standard platinum-based chemotherapy. If the cancer is diagnosed to have recurred, M-Trap devices with captured tumor cells will be removed via minimally invasive surgery (laparoscopy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites. | 6 months | 
| Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures | 30 days | 
| Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal | Time of device removal, an average of 13.3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of Participants With Device-related Long-term Adverse Event Reporting | Device-related long-term adverse events and serious adverse events reported through 18 months | 18 months | 
| Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting | Procedure-related long-term adverse events and serious adverse events reported through 18 months | 18 months | 
| Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization. | Time of recurrence, an average of 14.5 months |