Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

NCT03085238 | Completed Results DMC FDA Device

• 1 other identifier: MTRAP-2016-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV

Outcome Measures

Primary Outcomes (3)

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

  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.

  6 months

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

  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

  30 days

• Performance: Number of Participants With Histological Evidence of Tumor Cell Capture

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

  Time of device removal, an average of 13.3 months

Secondary Outcomes (3)

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

  18 months

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

  18 months

• 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 of recurrence, an average of 14.5 months

Other Outcomes (3)

• Number of Devices Implanted

  Immediately post-procedure

• Disease Focalization Score by Recurrence Status

  Time of recurrence, an average of 14.5 months

• Number of Participants With Reasons for Device Removal

  Time of device removal, an average of 13.3 months

Study Arms (1)

M-Trap

EXPERIMENTAL

Device: M-Trap

Interventions

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).

M-Trap

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTrap, Inc.: lead
• MedPass International: collaborator

Study Sites (8)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Castellon University General Hospital

Castelló, 12004, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital La Paz Madrid

Madrid, 28046, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Valencia-Hospital General

Valencia, 46014, Spain

Location

Hospital Universitrio y Politècnico La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Vice President, RA/QA/CA
• Organization: MTrap

cmitchell@m-trap.com

3013258537

Study Officials

• Antonio Gil-Moreno, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, non-blinded, single-arm study

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: March 9, 2017
• Primary Completion: September 12, 2018
• Study Completion: December 31, 2019
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)