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Microdevice for Ovarian Cancer
Study Summary
This trial is being conducted to assess the feasibility of using this device to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- The patient's CT scan shows that there is enough disease for the microdevice to be implanted.You need to have a lab test done within 14 days before the microdevice is placed.I cannot safely stop my blood thinner medication, except for low-dose aspirin.A specialist has confirmed I'm fit for surgery and biopsy for my condition.I can understand and am willing to sign the consent form.I agree to have my genes tested and shared anonymously for research.Your blood counts need to be within a certain range, and women who can have children must have a negative pregnancy test. If you're in cohort 4, you need to have these tests within 7 days before the microdevice placement.I have a bleeding or clotting disorder that makes surgery risky.I've had a CT scan of my abdomen/pelvis within the last 4 weeks to check for a safe spot for a device placement.My doctors agree I'm stable enough for surgery and other procedures.I have advanced ovarian, fallopian tube, or peritoneal cancer.I do not have any severe illnesses that would make surgery or biopsy unsafe.I am 18 years old or older.My disease has enough tissue for diagnosis even after removing the lesion for the microdevice.
- Group 1: Cohort 2: Surgical assessment for primary surgery
- Group 2: Cohort 4: Interval debulking surgery following neoadjuvant chemotherapy
- Group 3: Cohort 1: Primary cytoreduction
- Group 4: Cohort 3: Secondary cytoreduction
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the count of participants who have opted in to this research?
"Affirmative, according to clinicaltrials.gov's records this scientific trial is actively recruiting participants. The research was initially posted on November 1st 2022 and recently updated on the same day; it requires 20 individuals from 2 medical centres to participate in the study."
Could you elaborate on the potential risks associated with Microdevice technology?
"Our experts noted that there is limited safety data and efficacy evidence associated with microdevice, thus assigning it a score of 1."
Are there open slots for participants in this clinical experiment?
"Clinicaltrials.gov reports that this experiment is presently in the process of recruiting participants, with an initial post date on November 1st 2022 and a recent update on the same day."
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