Ovarian Cancer Stage IIICNCT03085238
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
A study testing M-Trap in people with Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV, run by MTrap, Inc. at 8 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
- What is being tested?
- M-Trap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 8 sitesSpain
- Study dates
- 9 Mar 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Castellon University General Hospital
Castelló, 12004
MD Anderson Cancer Center
Madrid, 28033
Hospital La Paz Madrid
Madrid, 28046
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
Valencia-Hospital General
Valencia, 46014
Hospital Universitrio y Politècnico La Fe
Valencia, 46026
About this study
Official title: Safety and Performance of 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.
- Conditions
- Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
- Being tested
- M-Trap
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TrapDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| M-Trap | Experimental | Not described Receives: Device: M-Trap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Device-related long-term adverse events and serious adverse events reported through 18 months
Measured: 18 months
Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
Procedure-related long-term adverse events and serious adverse events reported through 18 months
Measured: 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
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.
Measured: Time of recurrence, an average of 14.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start9 Mar 2017
- Primary completion12 Sep 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian Cancer Stage IIICStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, non-blinded, single-arm study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTrap, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- Antonio Gil-Moreno, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085238
- Sponsor's protocol ID
- MTRAP-2016-01
- Status last verified
- Jan 2020
- First submitted
- 15 Mar 2017
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03085238
- Acronym / sponsor ID
- MTRAP-2016-01
- Conditions
- Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MTrap, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, non-blinded, single-arm study
| Arm | Type | Receives |
|---|---|---|
| M-Trap | Experimental | Device: M-Trap |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- ECOG performance status of 0 or 1.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-TrapDevice(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). | Device | M-Trap |
Primary outcome
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.
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
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
3 secondary outcomes
Safety: Number of Participants With Device-related Long-term Adverse Event Reporting
Time frame: 18 months
Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
Time frame: 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 frame: Time of recurrence, an average of 14.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Gil-Moreno, MD principal investigator
Hospital Vall d'Hebron
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-Trap in people with Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV, run by MTrap, Inc. at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.