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Pilot Study Evaluating the Safety and Performance of the GeNO Nitrosyl Delivery System for Inhaled Nitric Oxide

2014-08-27 03:14:59 | BioPortfolio

Summary

This is an open label phase 2 Pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Pulmonary Arterial Hypertension

Intervention

GeNO nitrosyl delivery system

Status

Not yet recruiting

Source

Geno LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:59-0400

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