Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

MTrap, Inc.

Status: Completed

Conditions: Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV

Treatments: Device: M-Trap

Study type: Interventional

Funder types: Industry

Identifiers

NCT03085238

MTRAP-2016-01

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

M-Trap

Experimental group

Treatment:

Device: M-Trap