Strata Programmable CSF Shunt Valve Study
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|ClinicalTrials.gov Identifier: NCT02737163|
Recruitment Status : Terminated (Terminated early due to sufficient data acquired to meet our study objectives)
First Posted : April 13, 2016
Results First Posted : September 19, 2019
Last Update Posted : October 1, 2019
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 symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt reprogramming based on exposure to common environmental items.
|Condition or disease|
Investigators intend to evaluate all patients 21 years old and younger with magnetically susceptible CSF shunts, specifically those with Strata (Medtronic, Dublin) valves implanted. All evaluations will be performed during routine patient care in the hospital, the emergency department and in the outpatient facilities. Valve settings will be checked transcutaneously in the standard manner, before and after any MRI studies.
Evaluating IR and making correlations between exposure to MRI or environmental magnets and symptoms and radiographic changes (when available) will require the patient or family to complete a brief questionnaire. It will then require the study team and delegated providers to check the valve setting before and after MRI, and to gather clinical information from the medical record and from the current clinical evaluation.
Each patient's initial enrollment will require the acquisition of an informed consent, which will cover all future evaluations of IR during the three year study period for that patient. However, every time a patient enrolled in the study encounters the neurosurgical service, all study steps will be performed, including the valve check before and after MRI, the participant's completion of the questionnaire, and the research staff's completion of the data sheets.
|Study Type :||Observational|
|Actual Enrollment :||95 participants|
|Official Title:||Inadvertent Cerebral Spinal Fluid Valve Reprogramming: Prevalence and the Correlation With Signs, Symptoms, Radiographic Changes and the Exposure to Magnetic Fields.|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||June 8, 2017|
|Actual Study Completion Date :||June 8, 2017|
- Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves. [ Time Frame: 14 months ]Assessed by checking the valves at routine follow-up visits, in patient hospitalizations and prior to MRI imaging. The frequency will be calculated by the number of encounters/visits during which an assessed valve was inadvertently reprogrammed divided by the total number of encounters/visits in the trial. Here, we report the number of encounters/visits during which valves were inadvertently reprogrammed.
- Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths. [ Time Frame: 14 months ]Shunt valve settings were assessed before and after MRI studies using the 1.5 Tesla (T), 3 Tesla (T) or other MRI field strengths for any valve setting changes.
- Number of Encounters With Increased Signs, Symptoms and Radiographic Changes Suggestive of Shunt Malfunction in Participants With Inadvertent Reprogramming of the Strata Valve Compared to Those Without Inadvertent Reprogramming. [ Time Frame: 14 months ]Increased Signs, Symptoms and Radiographic Changes Suggestive of Shunt Malfunction in Participants With Inadvertent Reprogramming of the Strata Valve Compared to Those Without Inadvertent Reprogramming Assessment will be made using a family questionnaire and data sheet from clinical evaluation.
- Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge. [ Time Frame: 14 months ]Here we report the number of encounter/visits during which valves were inadvertently reprogrammed due to household devices with electromagnetic charge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737163
|United States, Florida|
|Johns Hopkins All Children's Hospital|
|Saint Petersburg, Florida, United States, 33701|
|Principal Investigator:||Gerald Tuite, MD||Johns Hopkins All Children's Hospital|