NCT01092559

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

An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Geno LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TREATMENT/FOLLOW-UP: Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Nitric Oxide generated by the GeNO nitrosyl delivery system	single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-03-25
• Last updated: 2013-06-04
• Results posted: 2013-06-04

Locations

3 sites across 1 country: United States