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NCT Number: NCT03085238

Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

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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Key information

Conditions

Ovarian Cancer Stage IIIC Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Stage IV Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <3 months.
  • Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating.
  • Will be receiving intraperitoneal chemotherapy.
  • Has undergone prior treatment with abdominal and/or pelvic radiotherapy.
  • 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.
  • Presence of central nervous system or cerebral metastases.
  • Recurrent ovarian cancer.
  • Complete resection with no residual tumor after primary tumor debulking surgery.
  • Suboptimal resection with >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.

Treatment and study plan

M-Trap

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).

Primary outcomes

  1. Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events

    Time frame: 6 months

    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.

  2. Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events

    Time frame: 30 days

    An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days 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, adjusted based on the breakdown of the historical control population by number of extended procedures

  3. Performance: Number of Participants With Histological Evidence of Tumor Cell Capture

    Time frame: Time of device removal, an average of 13.3 months

    Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal

Secondary outcomes

  1. Safety: Number of Participants With Device-related Long-term Adverse Event Reporting

    Time frame: 18 months

    Device-related long-term adverse events and serious adverse events reported through 18 months

  2. Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting

    Time frame: 18 months

    Procedure-related long-term adverse events and serious adverse events reported through 18 months

  3. 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

    Time frame: Time of recurrence, an average of 14.5 months

    Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization.

Other outcomes

  1. Number of Devices Implanted

    Time frame: Immediately post-procedure

    Number of devices implanted at conclusion of debulking surgery.

  2. Disease Focalization Score by Recurrence Status

    Time frame: Time of recurrence, an average of 14.5 months

    Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device

  3. Number of Participants With Reasons for Device Removal

    Time frame: Time of device removal, an average of 13.3 months

    Reason that device removal was planned, regardless of whether or not it was completed.

Sponsors and collaborators

Lead sponsor

MTrap, Inc.

Industry

Collaborators

  • MedPass International

Registry information

Official study title

Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 21, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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