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The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique

NCT01007786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2012-06-14

No results posted yet for this study

Summary

Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve. The purpose of this study is to assess the efficacy and safety of the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The primary outcome measure is ventricular catheter location determined from post-operative brain images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo conventional shunt surgery will serve as a contemporary control group.

Conditions

  • Pediatric Hydrocephalus

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Utah

    lead OTHER

Principal Investigators

  • William Whitehead, MD, MPH · HCRN, Texas Children's Hospital

  • Jay Riva-Cambrin, MD · HCRN, Primary Children's Medical Center

  • Abhaya Kulkarni, MD, PhD · HCRN, Sick Children's Hospital, Toronto, Ontario

  • Jay Wellons, MD · HCRN, Children's Hosptial of Alabama

  • John Kestle, MD · Chair, Hydrocephalus Clinical Research Network

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-02-28
Completion
2011-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01007786 on ClinicalTrials.gov