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Adjustable Gravitational vs. Adjustable Differential Pressure Valves in iNPH

NCT04434053 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-06-16

No results posted yet for this study

Summary

The goal of the study is to verify theoretical benefit of ventriculoperitoneal shunting with MIETHKE M.blue® valve in patients with iNPH. The study is designed to assess walking and balance, urinary function, cognitive performance and quality of life before and after shunting and compare the results between the patients with MIETHKE M.blue® and MIETHKE proGAV 2.0® (with SA 2.0®) valves.

Conditions

  • Normal Pressure Hydrocephalus

Interventions

DEVICE

MIETHKE M.blue®

The programmable shunt will be adjusted through the MIETHKE M.blue® valve.

DEVICE

MIETHKE proGAV 2.0® (with SA 2.0®)

The programmable shunt will be adjusted through the MIETHKE proGAV 2.0® valve that will be implanted together with a shunt-assistant SA 2.0®.

Sponsors & Collaborators

  • Military University Hospital, Prague

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-01-01
Completion
2023-01-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434053 on ClinicalTrials.gov