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Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer | Clinical Trials | Clareo Health

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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

NCT03085238•MTrap, Inc.

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

Age

18 - No limit years

Sex

FEMALE

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.
+3 more criteria

Locations (8)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Castellon University General Hospital

Castelló, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital La Paz Madrid

Madrid, Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Valencia-Hospital General

Valencia, Spain

Hospital Universitrio y Politècnico La Fe

Valencia, Spain

Key Dates

Start Date

March 9, 2017

Primary Completion Date

September 12, 2018

Completion Date

December 31, 2019

Last Updated

January 27, 2020

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer Stage IIICOvarian Cancer Stage IV

Interventions

M-Trap

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer .

Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

Reduction Of Cycles of neOadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer