Trials / Completed
CompletedNCT03085238
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- MTrap, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2017-03-09
- Primary completion
- 2018-09-12
- Completion
- 2019-12-31
- First posted
- 2017-03-21
- Last updated
- 2020-01-27
- Results posted
- 2020-01-27
Locations
8 sites across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03085238. Inclusion in this directory is not an endorsement.