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Transnasal Induction of Normothermia in Febrile Stroke Patients

NCT03360656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-18

Study results available
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Summary

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Conditions

  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Fever
  • Seizures
  • Metabolic Encephalopathy

Interventions

DEVICE

Transnasal Thermal Regulating Device

Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

Sponsors & Collaborators

  • CoolTech LLC

    lead INDUSTRY

Principal Investigators

  • Neeraj Badjatia, MD MS · Univ of Maryland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2022-04-22
Completion
2022-04-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03360656 on ClinicalTrials.gov