Recruiting

Ommaya Reservoir

Sponsor:

Mayo Clinic

Code:

NCT04692337

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-operative Ommaya Reservoir placement

Study Details

Brief summary:

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.

Conditions

Brain Tumor

Study ID

NCT04692337

Start date

Jan 15, 2021

Status verified date

Aug, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years.
  • Clinical and radiographic evidence suggesting a diagnosis of a brain tumor.
  • Planned neurosurgical procedure resection of suspected or previously diagnosed brain tumor as part of routine clinical care.
  • Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).
  • Willingness of the patient or an authorized representative to provide informed consent
  • Patient is willing to have their Ommaya sampled on at least 2 future occasions.
  • Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)

Exclusion Criteria:

  • Vulnerable populations including pregnant women, prisoners and individuals <18 years old.
  • 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
  • Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons could (but need not necessarily) include factors related to surgical anatomy, clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns.
  • Any patient for whom a clinical contraindication exists to a lumbar puncture (LP) will be excluded from the LP portion of this protocol, but would still be eligible for an Ommaya reservoir if they meet the inclusion criteria of the study. For example, a patient with a large posterior fossa mass lesion at risk of herniation, or a patient with coagulopathy, or other contraindication to lumbar puncture would not be eligible to participate via use of lumbar puncture for CSF access

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Intra-operative Ommaya Reservoir placement

An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.

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 ]
  • Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times [ Time Frame: Through study completion, approximately 42 days ]
  • Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtained [ Time Frame: Through study completion, approximately 42 days ]

Central Contacts and Locations

Central contacts

Essa Sharif

507-538-6342sharif.essa@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Essa Sharif

507-538-6342sharif.essa@mayo.edu

Principal Investigator:

Terry C. Burns, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-10.