Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geno LLC
ClinicalTrials.gov Identifier:
NCT01092559
First received: February 16, 2010
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
Results First Received: April 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nitric Oxide Via GeNO Nitrosyl System Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.

Participant Flow:   Overall Study
    Nitric Oxide Via GeNO Nitrosyl System  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Nitric Oxide Via GeNO Nitrosyl System Nitric Oxide via GeNO Nitrosyl System

Baseline Measures
    Nitric Oxide Via GeNO Nitrosyl System  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  51  ± 15.17  
Gender  
[units: participants]
 		 
Female     8  
Male     2  
Region of Enrollment  
[units: participants]
 		 
United States     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.   [ Time Frame: through Day 30 Follow-up Period ]
  Show Outcome Measure 1

2.  Primary:   Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation   [ Time Frame: through Treatment Period ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None  


Results Point of Contact:  
Name/Title: Director of Clinical Development
Organization: GeNO, LLC
phone: 321-785-2613
e-mail: matthew.rush@genollc.com


No publications provided


Responsible Party: Geno LLC
ClinicalTrials.gov Identifier: NCT01092559     History of Changes
Other Study ID Numbers: P2010-001
Study First Received: February 16, 2010
Results First Received: April 18, 2013
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration