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Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

NCT03085238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-01-27

Study results available
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Summary

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.

Conditions

  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IV

Interventions

DEVICE

M-Trap

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).

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • MTrap, Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio Gil-Moreno, MD · Hospital Vall d'Hebron

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-09-12
Completion
2019-12-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085238 on ClinicalTrials.gov