RECRUITING

ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Conditions

Pseudotumor Cerebri Pseudotumor Cerebri, Ventriculoperitoneal Shunt

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

Official Title

Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri

Quick Facts

Study Start:2019-10-29

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04309383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18 years old or older Adult men or women who possess a VP shunt placed for PTC; * Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent; * Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op	* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; * ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; * Presence of an interfering open wound or edema over any portion of the VP shunt.

Inclusion Criteria

Exclusion Criteria

* 18 years old or older Adult men or women who possess a VP shunt placed for PTC;
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
* Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the VP shunt.

Contacts and Locations

Study Contact

Naomi Abel, MD

CONTACT

813 259-0904

nabel@usf.edu

Thanh Tran

CONTACT

813 844 8544

tqtran@usf.edu

Principal Investigator

Naomi Abel, MD

PRINCIPAL_INVESTIGATOR

University of South Florida

Study Locations (Sites)

University of South Florida Department of Neurological Surgery and Brain Repair

Tampa, Florida, 33606

United States

Collaborators and Investigators

Sponsor: University of South Florida

Naomi Abel, MD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-29

Study Completion Date2025-01

Study Record Updates

Study Start Date2019-10-29

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

Pseudotumor Cerebri, Ventriculoperitoneal Shunt

Additional Relevant MeSH Terms

Pseudotumor Cerebri