N/A
N=23
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
Ovarian Cancer Stage IIIC · Ovarian Cancer Stage IV
Bottom Line
View on ClinicalTrials.gov: NCT03085238 ↗Enrolled (actual)
23
Serious AEs
47.8%
Results posted
Jan 2020
Primary outcome: Primary: Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events — 18 Participants — p=0.1309
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- M-Trap (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MTrap, Inc.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events |
20 | .0181 sig |
| PRIMARY Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events |
20 | .0181 sig |
| PRIMARY Performance: Number of Participants With Histological Evidence of Tumor Cell Capture |
2; 6; 2; 8; 10 | — |
| SECONDARY Safety: Number of Participants With Device-related Long-term Adverse Event Reporting |
1 | — |
| SECONDARY Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting |
21 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03085238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.