MedTrace Logo

A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation

NCT02305550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-02-10

No results posted yet for this study

Summary

Study Design: This is a two-part physiological for a device feasibility. Both studies are proof of concept descriptive pilot studies.

The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).

Volunteers and patients will be enrolled sequentially; there is no group randomization.

Overall hypothesis of this device feasibility study: To test a lightweight and portable method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical pulsed discharge.

Conditions

  • Hypertension, Pulmonary

Interventions

DEVICE

electrical pulsed plasma discharge synthesis of nitric oxide

An NO generator was designed and developed by electrical pulsed plasma discharge nitric oxide from atmospheric nitrogen and oxygen. This generator has been fabricated by the investigators and it is not commercially available.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lorenzo Berra, MD · MGH

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02305550 on ClinicalTrials.gov