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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
Must not have
Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness
Prior history of any wound infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 42 days
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have surgery due to my health condition or another serious illness.
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I have had an infection in a wound before.
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I am not pregnant, imprisoned, or under 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events of intra-operative Ommaya Reservoir placement
Intra-operative Ommaya Reservoir placement

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,339 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,357 Previous Clinical Trials
3,062,591 Total Patients Enrolled
Terry C. Burns, MD, PhDPrincipal InvestigatorMayo Clinic
Terry C Burns, MD, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
310 Total Patients Enrolled

Media Library

Intra-operative Ommaya Reservoir placement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04692337 — N/A
Brain Tumor Research Study Groups: Ommaya Reservoir placement
Brain Tumor Clinical Trial 2023: Intra-operative Ommaya Reservoir placement Highlights & Side Effects. Trial Name: NCT04692337 — N/A
Intra-operative Ommaya Reservoir placement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692337 — N/A
~6 spots leftby Jul 2025
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