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Procedure
Ommaya Reservoir Placement for Brain Cancer
N/A
Recruiting
Led By Terry C Burns, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN)
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 42 days
Awards & highlights
Study Summary
This trial will test whether it is safe to place a medical device called an Ommaya reservoir during surgery for brain tumors. The device will be used to study potential biomarkers for brain tumors.
Who is the study for?
Adults over 18 with a suspected or diagnosed brain tumor who are undergoing surgery at Mayo Clinic in Rochester, MN. Participants must be willing to sign consent forms and allow their cerebrospinal fluid (CSF) to be collected for research. Pregnant women, prisoners, minors, those not fit for surgery due to medical history or illness, and individuals with infection risks like diabetes or smoking are excluded.Check my eligibility
What is being tested?
The trial is testing the safety of placing an Ommaya Reservoir into the brain during tumor removal surgery. This device will provide ongoing access to CSF for biomarker analysis and monitoring throughout the treatment process.See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as infection risk around the reservoir site, possible immune system reactions due to repeated CSF sampling through the Ommaya Reservoir.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to have brain surgery at Mayo Clinic in Rochester, MN.
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I am older than 18 years.
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I am scheduled for brain surgery to remove a tumor.
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I have signs and scans indicating a brain tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events of intra-operative Ommaya Reservoir placement
Intra-operative Ommaya Reservoir placement
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ommaya Reservoir placementExperimental Treatment1 Intervention
Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,855 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,084 Total Patients Enrolled
Terry C Burns, MD, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
310 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to have brain surgery at Mayo Clinic in Rochester, MN.I cannot have surgery due to my health condition or another serious illness.I have had an infection in a wound before.The surgeon doesn't think it's a good idea to place the Ommaya reservoir in the patient for reasons like the patient's anatomy, weakened immune system, or high risk of infection due to health conditions like diabetes, smoking, or obesity.I am older than 18 years.You are willing to have fluid from a device called Ommaya sampled at least two times in the future.I am not pregnant, imprisoned, or under 18.I am scheduled for brain surgery to remove a tumor.I have signs and scans indicating a brain tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Ommaya Reservoir placement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research program currently have openings for participants?
"Affirmative, the information published on clinicaltrials.gov attests that this scientific investigation is actively seeking applicants. This trial was first posted on January 15th 2021 and most recently updated July 18th 2022; 50 patients need to be recruited from a single site in order to proceed with the experiment."
Answered by AI
To what extent is the patient pool for this clinical experiment being assessed?
"Affirmative, according to clinicaltrials.gov's database, the research is actively seeking participants. This clinical trial was first revealed on January 15th 2021 and has recently been modified as of July 18th 2022. There are 50 patients needed from a single medical facility."
Answered by AI
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