Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04692337
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intra-operative Ommaya Reservoir placement — PROCEDURE
    An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.

Study Details

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.

Key Dates

Start date
Jan 15, 2021
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ommaya Reservoir placement
    Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery.

Primary Outcome Measure

Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients [ Time Frame: Through study completion, approximately 42 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Essa Sharif
[email protected]
507-538-6342
Terry C. Burns, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By specialty
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Mayo Clinic in Rochester· Rochester, MN

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