18 and older, female only, with Ovarian Cancer Stage IIIC or Ovarian Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse EventsPrimary· 6 months
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 inf
Group
Value
95% CI
M-Trap
18
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse EventsPrimary· 30 days
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, inc
Group
Value
95% CI
M-Trap
20
Performance: Number of Participants With Histological Evidence of Tumor Cell CapturePrimary· Time of device removal, an average of 13.3 months
Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal
Group
Value
95% CI
Platinum Resistant, Recurrent Patients
2
Platinum Sensitive, Recurrent Patients
6
Non-recurrent
2
All Recurrent Patients
8
All Patients
10
Safety: Number of Participants With Device-related Long-term Adverse Event ReportingSecondary· 18 months
Device-related long-term adverse events and serious adverse events reported through 18 months
Group
Value
95% CI
M-Trap
1
Safety: Number of Participants With Procedure-related Long-term Adverse Event ReportingSecondary· 18 months
Procedure-related long-term adverse events and serious adverse events reported through 18 months
Group
Value
95% CI
M-Trap
21
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 StatusSecondary· Time of recurrence, an average of 14.5 months
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.
Group
Value
95% CI
M-Trap Platinum Resistant Recurrent
0
Platinum Sensitive, Recurrent Patients
0
Non-recurrent
0
All Recurrent Patients
0
All Patients
0
M-Trap Platinum Resistant Recurrent
0
Platinum Sensitive, Recurrent Patients
0
Non-recurrent
0
All Recurrent Patients
0
All Patients
0
M-Trap Platinum Resistant Recurrent
0
Platinum Sensitive, Recurrent Patients
1
Non-recurrent
0
All Recurrent Patients
1
All Patients
1
M-Trap Platinum Resistant Recurrent
2
Platinum Sensitive, Recurrent Patients
7
Non-recurrent
0
All Recurrent Patients
9
All Patients
9
Number of Devices ImplantedSecondary· Immediately post-procedure
Number of devices implanted at conclusion of debulking surgery.
Group
Value
95% CI
M-Trap
1
M-Trap
22
Disease Focalization Score by Recurrence StatusSecondary· Time of recurrence, an average of 14.5 months
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
Group
Value
95% CI
M-Trap Platinum Resistant Recurrent
0
Platinum Sensitive, Recurrent Patients
0
Non-recurrent
0
All Recurrent Patients
0
All Patients
0
M-Trap Platinum Resistant Recurrent
0
Platinum Sensitive, Recurrent Patients
0
Non-recurrent
0
All Recurrent Patients
0
All Patients
0
M-Trap Platinum Resistant Recurrent
0
Platinum Sensitive, Recurrent Patients
1
Non-recurrent
0
All Recurrent Patients
1
All Patients
1
M-Trap Platinum Resistant Recurrent
2
Platinum Sensitive, Recurrent Patients
6
Non-recurrent
0
All Recurrent Patients
8
All Patients
8
Number of Participants With Reasons for Device RemovalSecondary· Time of device removal, an average of 13.3 months
Reason that device removal was planned, regardless of whether or not it was completed.
Group
Value
95% CI
M-Trap
1
M-Trap
15
M-Trap
5
M-Trap
1
Tumor Cell InfiltrationSecondary· Time of recurrence, an average of 14.5 months
Estimate of tumor cell infiltration into the device based on histopathological analysis of devices from recurrent patients who underwent successful device removal. Percentage of device was determined by analysis of one slide from one tissue block (0.3 cm thick), by considering the amount of tumor cells in comparison to the total number of cells present in the slide when analyzed using image analysis with a digital slide scanner \[Membrane Quant Module, Panoramic 250 FLASH II 2.0 (3D HISTEC)\].
Group
Value
95% CI
M-Trap
1.7
± 2.5
Adverse events — posted to ClinicalTrials.gov
Time frame: 18 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MTrap, Inc.
Last refreshed: 27 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03085238.