Strata Programmable CSF Shunt Valve Study
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|ClinicalTrials.gov Identifier: NCT02737163|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : April 27, 2017
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|
|Estimated Enrollment :||1000 participants|
|Official Title:||Inadvertent Cerebral Spinal Fluid Valve Reprogramming: Prevalence and the Correlation With Signs, Symptoms, Radiographic Changes and the Exposure to Magnetic Fields.|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2020|
- Frequency of inadvertent reprogramming of strata CSF shunt valves. [ Time Frame: April 2016 through May 2019 ]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 times the assessed valves is inadvertently reprogrammed divided by the total number of assessed valves in the trial.
- The likelihood of MRI field strength in reprogramming the strata valve. [ Time Frame: April 2016 through May 2019 ]Assessments made before and after MRI studies for 1.5 Tesla, 3 Tesla or other MRI field strengths.
- 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: April 2016 through May 2019 ]Assessment will be made using a family questionnaire and data sheet.
- The likelihood of inadvertent reprogramming with exposure to household devices with electromagnetic charge. [ Time Frame: April 2016 through May 2019 ]Based on responses to questionnaires about exposure to such devices, analyses will be performed to determine the relative risk of inadvertent reprogramming when exposure to such devices (eg: iPad, cellular telephone, magnets, etc.).
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
|Contact: Lisa Tetreault, RN,BSNfirstname.lastname@example.org|
|Contact: Gerald Tuite, MDemail@example.com|
|United States, Florida|
|Johns Hopkins All Children's Hospital||Recruiting|
|Saint Petersburg, Florida, United States, 33701|
|Contact: Lisa Tetreault, RN, BSN 727-767-2081 firstname.lastname@example.org|
|Principal Investigator: Gerald Tuite, MD|
|Principal Investigator:||Gerald Tuite, MD||Johns Hopkins All Children's Hospital|