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A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial

NCT03350750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-08-02

Study results available
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Summary

The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.

Conditions

  • Idiopathic Normal Pressure Hydrocephalus (INPH)

Interventions

DEVICE

programmable CSF shunt valve

Brain shunt surgery using a programmable CSF shunt valve

Sponsors & Collaborators

Principal Investigators

  • Mark Luciano, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2021-03-19
Completion
2021-05-18
FDA Device
Yes

Countries

  • United States
  • Canada
  • Sweden

Study Locations

More Related Trials

Entities

Companies

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 NCT03350750 on ClinicalTrials.gov