Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT03085238
• Recruitment Status: Completed
• First Posted: March 21, 2017
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: MTrap, Inc.
• Collaborator: MedPass International
• Information provided by (Responsible Party): MTrap, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV	Device: M-Trap	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, multi-center, non-blinded, single-arm study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
• Actual Study Start Date: March 9, 2017
• Actual Primary Completion Date: September 12, 2018
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: M-Trap

Device: 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Castellon University General Hospital

Castelló, Spain, 12004

MD Anderson Cancer Center

Madrid, Spain, 28033

Hospital La Paz Madrid

Madrid, Spain, 28046

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain, 15706

Valencia-Hospital General

Valencia, Spain, 46014

Hospital Universitrio y Politècnico La Fe

Valencia, Spain, 46026

Sponsors and Collaborators

MTrap, Inc.

MedPass International

Investigators

• Principal Investigator: Antonio Gil-Moreno, MD; Hospital Vall d'Hebron

  Study Documents (Full-Text)

Documents provided by MTrap, Inc.:

Study Protocol  [PDF] September 12, 2017

Statistical Analysis Plan  [PDF] September 10, 2019

More Information

• Responsible Party: MTrap, Inc.
• ClinicalTrials.gov Identifier: NCT03085238
• Other Study ID Numbers: MTRAP-2016-01
• First Posted: March 21, 2017
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasm Metastasis; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes