RECRUITING

Intraventricular Catheter System for IVH

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 this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.

Official Title

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Quick Facts

Study Start:2022-06-14
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05970549

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>=18 years of age
  2. * Intraventricular hemorrhage documented on head CT or MRI scan
  3. * Need of cerebrospinal fluid drainage
  4. * Indication for active treatment evaluated by the treating physicians
  5. * Signed informed consent obtained by patient or Legal Authorized Representative
  6. * Treatment possible within 72 hours of ictus
  1. * Patient has fixed and dilated pupils
  2. * Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)

Contacts and Locations

Study Contact

Christopher P Kellner, MD
CONTACT
212-241-2606
christopher.kellner@mountsinai.org
Trevor Hardigan, MD PhD
CONTACT
212-241-2606
trevor.hardigan@mountsinai.org

Principal Investigator

Christopher P Kellner, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10128
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Christopher P Kellner, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Date2022-06-14
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-06-14
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Intraventricular Hemorrhage (IVH)