CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Nitric Oxide generated by the GeNO nitrosyl delivery systemdrug
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/NCT01092559
NCT01092559Phase 2Completed
CompareCT.gov

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

Geno LLC·interventional·Posted Mar 25, 2010·Updated Jun 4, 2013

In Brief

A Phase 2 clinical trial evaluating Nitric Oxide generated by the GeNO nitrosyl delivery system for Pulmonary Arterial Hypertension. Completed, enrolled 10 participants across 3 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2010
Enrollment StartOct 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.3 years ago

Interventions

Nitric Oxide generated by the GeNO nitrosyl delivery systemdrug

single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.