Trial Outcomes & Findings for Strata Programmable CSF Shunt Valve Study (NCT NCT02737163)

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

95 participants

Primary outcome timeframe

14 months

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Observational Single Ecounter Assessment Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at "single" encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findings.
Overall Study STARTED	95
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Strata Programmable CSF Shunt Valve Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational Single Encounter Assessment n=113 encounters Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at "single" encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findings.
Age, Categorical <=18 years	88 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	42 Participants n=93 Participants
Sex: Female, Male Male	53 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Observational Single Ecounter Assessment n=114 Encounters Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at "single" encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findidngs.
Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves.	15 Encounters

SECONDARY outcome

Timeframe: 14 months

Population: Data collected from 91 encounters who underwent MRI either on the 1.5 T or the 3 T as part of their visit

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.

Outcome measures

Outcome measures
Measure	Observational Single Ecounter Assessment n=91 encounters Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at "single" encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findidngs.
Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths. 1.5 T MRI valve changes · valve changes	76 encounters
Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths. 1.5 T MRI valve changes · no valve change	15 encounters
Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths. 3T MRI valve changes · valve changes	78 encounters
Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths. 3T MRI valve changes · no valve change	13 encounters

SECONDARY outcome

Timeframe: 14 months

Population: Data collected from the 15 participants with inadvertent reprogramming.

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.

Outcome measures

Outcome measures
Measure	Observational Single Ecounter Assessment n=15 encounters with reprogramming Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at "single" encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findidngs.
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.	7 encounters - signs of shunt malfunction

SECONDARY outcome

Timeframe: 14 months

Here we report the number of encounter/visits during which valves were inadvertently reprogrammed due to household devices with electromagnetic charge.

Outcome measures

Outcome measures
Measure	Observational Single Ecounter Assessment n=114 encounters Pediatric patients with adjustable cerebral spinal fluid shunt valves were assessed at "single" encounters when scheduled for an MRI. Assessment included questionnaires that assessed multiple variables that have been previously associated with inadvertent reprogramming, including proximity to magnets, iPads and cell phones. Valve settings were assessed before and after the MRI and data collected regarding history, clinical and imaging findidngs.
Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge.	15 encounters

Adverse Events

Observational Single Ecounter Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerald Tuite, MD

Johns Hopkins All Children's Hospital

Phone: 7277678181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place