Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multi-center, non-blinded, single-arm study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M-Trap

Group Type EXPERIMENTAL

M-Trap

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No