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Virus Therapy

electrical synthesis nitric oxide for Pulmonary Hypertension

N/A
Waitlist Available
Led By Lorenzo Berra, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Carboxyhemoglobin
Methemoglobin
Oxygenation
Secondary study objectives
Cyclic guanosine monophosphate
Pulmonary artery pressure

Side effects data

From 2021 Phase 4 trial • 519 Patients • NCT03081052
28%
Venous Thromboemolic DVT
13%
Venous Thromboembolic Other
11%
New Onset Atrial Fibrillation
9%
All Cause Mortality
6%
Arterial Thromboembolic CVA/Stroke
5%
Venous Thromboembolic PE
3%
Arterial Thromboembolic Mesenteric Ischemia
2%
Arterial Thromboembolic Myocardial Infarction
2%
Upper GI Bleed
1%
Lower GI Bleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lung Transplant With iNO
Lung Transplant With iEPO
Heart Transplant & LVAD Implantation With iNO
Heart Transplant & LVAD Implantation With iEPO

Trial Design

1Treatment groups
Experimental Treatment
Group I: electrical synthesis nitric oxideExperimental Treatment1 Intervention
Participants will breath 20 minutes of electrical pulsed plasma discharge synthesis of nitric oxide at 25 parts per million
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
electrical pulsed plasma discharge synthesis of nitric oxide
2015
N/A
~20

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,997 Previous Clinical Trials
13,231,468 Total Patients Enrolled
Lorenzo Berra, MDPrincipal InvestigatorMGH
16 Previous Clinical Trials
822 Total Patients Enrolled
~1 spots leftby Sep 2025
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