Clinical trial · Interventional
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
NCT03085238CI-TRIAL-00043014completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer Stage IIIC | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer Stage IV | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M-Trap | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- M-Trap
- interventionNames
- Device: M-Trap
Primary outcomes (3)
- measure
- Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
- timeFrame
- 6 months
- description
- 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.
- measure
- Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Is a female ≥18 years old. 2. Presents with a diagnosis of Stage IIIC ovarian cancer. 3. Presents with high-grade serous carcinoma. 4. Has one of the following: 1. Visible residual tumor ≤1 cm after primary tumor debulking surgery. 2. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery. 3. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery. 5. ECOG performance status of 0 or 1. 6. Is willing to comply with required follow-up study visits. 7. Is willing and able to provide written informed consent. Exclusion Criteria: 1. Has a life expectancy of \<3 months. 2. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating. 3. Will be receiving intraperitoneal chemotherapy. 4. Has undergone prior treatment with abdominal and/or pelvic radiotherapy. 5. 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. 6. Presence of central nervous system or cerebral metastases. 7. Recurrent ovarian cancer. 8. Complete resection with no residual tumor after primary tumor debulking surgery. 9. Suboptimal resection with \>1 cm residual tumor after primary or interval tumor debulking surgery. 10. Is simultaneously enrolled in another investigational study. 11. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer. 12. Has a known hypersensitivity to carboplatin or paclitaxel. 13. Is concurrently using other antineoplastic agents.
References
Publications (0)
Data not yet available
No reference posted for this study.