Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Ovarian Cancer

Ovarian Epithelial Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

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

Antonio Gil-Moreno, MD

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.

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

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

Number of devices implanted at conclusion of debulking surgery.

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

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

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.

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

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

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

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

MedPass International

MTrap, Inc.

Any adverse event (AE) observed was fully investigated by the Investigator and classified in line with the definitions of the ISO 14155:2011. AEs were collected from patients and their medical records at each follow-up interval (discharge, 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months).

M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Spain

Region of Enrollment

Staging is the process of finding out how much cancer is in a person's body and where it's located.

Stage IIIC: Cancer has spread to the peritoneum and the cancer in the peritoneum is larger than 2 centimeters and/or cancer has spread to lymph nodes in the abdomen.

Stage IVA: Cancer cells are found in extra fluid that has built up around the lungs.

Stage IVB: Cancer has spread to organs and tissues outside the abdomen, including lymph nodes in the groin.

Ovarian Cancer Stage

Eastern Cooperative Oncology Group GRADE 0 Fully active, able to carry on all pre-disease performance without restriction GRADE 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature GRADE 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours GRADE 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours GRADE 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair GRADE 5 Dead

ECOG Performance Status

Pregnancy

Primary debulking has no chemotherapy treatment prior to the debulking surgery. Interval debulking has 3 to 4 rounds of chemotherapy treatment prior to the debulking surgery with the aim of reducing the tumor burden prior to surgery.

Type of debulking procedure

All patients

Primary debulking

Interval debulking

Peritoneal cancer index (PCI) - assesses extent of peritoneal cancer in peritoneal cavity. Peritoneal cavity is divided in 13 well-defined regions. In each region, the size of the largest tumor nodule is measured. If no tumor is visualized, score is "0". If the largest tumor nodule is smaller than 0.5 cm, score is "1". If tumor measures between 0.5 cm and 5 cm, score is "2". If lesion is larger than 5 cm, the score is "3". If layering or a confluence of multiple small tumor nodules, score is "3". PCI is calculated by adding the scores of all regions together with a max of 39 (13×3).

Analysis on complete population and sub-analysis by type of debulking surgery.

Pre-debulking PCI

Measure Analysis Population Description: Analysis on complete population and sub-analysis by type of debulking surgery.

Post-debulking PCI

Pre-operative serum albumin

Pre-operative hemoglobin

1 extended procedure

2 extended procedures

3 or more extended procedures

Total number of extended procedures per the Patankar definition. Extended procedures of interest included lymphadenectomy, small bowel resection, colectomy, rectosigmoid resection, hepatic resection, bladder resection, diaphragm resection and cytoreduction.

Total number of extended procedures

Vice President, RA/QA/CA

H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)

M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.

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

Tumor cell capture in at least one device in patients determined to be recurrent and platinum-resistant

Platinum Resistant, Recurrent Patients

Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive

Platinum Sensitive, Recurrent Patients

Tumor cell capture in at least one device in patients who did not demonstrate recurrence

Non-recurrent

Tumor cell capture in at least one device in patients determined to be recurrent

All Recurrent Patients

Tumor cell capture in at least one device in all patients

All Patients

Assessment was completed in all patients who underwent successful device removal.

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

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

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

M-Trap Platinum Resistant Recurrent

Tumor cell capture in at least one device in patients determined to be non-recurrent

Tumor cell capture in at least one device in all patients determined to be recurrent

All patients with disease focalization scores reported

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

Number of Devices Implanted

Disease Focalization Score by Recurrence Status

M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at the time of surgical debulking.

Number of Participants With Reasons for Device Removal

Estimate of tumor cell infiltration into the device based on histopathological analysis of devices from recurrent patients who underwent successful device removal. Percentage of device was determined by analysis of one slide from one tissue block (0.3 cm thick), by considering the amount of tumor cells in comparison to the total number of cells present in the slide when analyzed using image analysis with a digital slide scanner \[Membrane Quant Module, Panoramic 250 FLASH II 2.0 (3D HISTEC)\].

Recurrent patients who underwent successful device removal

Spots Global Cancer Trial Database for Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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