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NCT02737163 · ClinicalTrials.gov registry record
Strata Programmable CSF Shunt Valve Study
A clinical trial, sponsored by Johns Hopkins All Children's Hospital.
- Terminated
- Registry status
- 95
- Enrollment target
NCT02737163 is a clinical trial that was terminated before completion, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 95 participants.
The verdict
NCT02737163 was terminated before completion, sponsored by Johns Hopkins All Children's Hospital.
- TERMINATED
- Registry status
- 95 participants
- Enrollment target
Study Summary
The treatment of hydrocephalus is the most time consuming, and arguably the most important role of the pediatric neurosurgical service at most children's' hospitals. Despite many technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated with high complication rates and account for a disproportionate share of health care expenditures and morbidity. Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick and painless transcutaneous reprogramming, have been implanted for more than 15 years in the developed world. Reprogramming these valves relies on rotational magnetic forces, which are applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields in the environment, which may lead to serious symptoms that may require urgent reprogramming and/or surgery. The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and household items that generate substantial magnetic fields has caused concern among patients, parents and providers about the potential consequences of inadvertent valve reprogramming. This growing concern led the FDA to issue a warning to individuals with programmable valves in 2014, which deemed the programmable valves safe for use but vulnerable to IR when household devices such as tablets or cell phones are placed within 2 inches of the valve. The FDA recommended further study, stating that no systematic evaluation had been performed regarding the prevalence of accidental valve adjustments. By evaluating each of the patients with magnetically susceptible CSF shunt valves, during each of the routine points of contact with the service, investigators aim to define the prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2017-06-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02737163
The ClinicalTrials.gov registry entry for NCT02737163 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins All Children's Hospital, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02737163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02737163 about?
NCT02737163 is a clinical study titled "Strata Programmable CSF Shunt Valve Study". The treatment of hydrocephalus is the most time consuming, and arguably the most important role of the pediatric neurosurgical service at most children's' hospitals. Despite many technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay of hydrocephalus treatment. W...
What is the current status of trial NCT02737163?
This trial is currently terminated. The enrollment target is 95 participants. The study started on 2016-04-01. Estimated completion is 2017-06-08.
Who is sponsoring clinical trial NCT02737163?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
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