Strata Programmable CSF Shunt Valve Study

NCT02737163 | Terminated Results

• 1 other identifier: IRB00093490
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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 symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt reprogramming based on exposure to common environmental items.

Conditions

Hydrocephalus

Keywords

Programmable shunts; Strata valve

Outcome Measures

Primary Outcomes (1)

• Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves.

  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.

  14 months

Secondary Outcomes (3)

• Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths.

  14 months

• 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.

  14 months

• Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge.

  14 months

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients 21 years of age and younger, with Strata valve CSF shunts, who are being evaluated by the All Children's Hospital (ACH) neurosurgical service as part of standard of care, will be eligible for participation during the three-year enrollment period. Each time an eligible patient has contact with the neurosurgical service their valve will be checked for possible inadvertent reprogramming in the outpatient facilities, emergency department, and inpatient setting. Patients will only have their valves checked as part of this study once during each encounter. Only patients who were evaluated by the neurosurgical service and returned to their normal environment more than seven days prior to their current encounter will be eligible to have their valves rechecked as part of this study.

You may qualify if:

• Patients 21 years of age and younger
• With Strata valve CSF shunts
• Who are being evaluated by the All Children's Hospital (ACH) neurosurgical service as part of standard of care

You may not qualify if:

• Patients older than 21 years of age
• Do not have a Strata CSF shunt valve
• Not patients of the All Children's Hospital neurosurgical service

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Gerald Tuite, MD
• Organization: Johns Hopkins All Children's Hospital

gtuite1@jhmi.edu

7277678181

Study Officials

• Gerald Tuite, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: July 3, 2023
• Results First Posted: September 19, 2019

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)