CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
electrical pulsed plasma discharge synthesis of nitric oxidedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02305550
NCT02305550N/ACompleted
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A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation

Massachusetts General Hospital·interventional·Posted Dec 2, 2014·Updated Feb 10, 2017

In Brief

A clinical study evaluating electrical pulsed plasma discharge synthesis of nitric oxide for Hypertension, Pulmonary. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2, 2014
Enrollment StartApr 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.6 years ago

Interventions

electrical pulsed plasma discharge synthesis of nitric oxidedevice

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.