Trial Outcomes & Findings for Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide (NCT NCT01092559)
NCT ID: NCT01092559
Last Updated: 2013-06-04
Results Overview
Adverse Event Severity \[through Day 30 Follow-Up Period\] Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms \[through discharge from Treatment Period\] Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin. \[through discharge from Treatment Period\] Vital Signs: pulse, blood pressure, respiratory rate \[through discharge from Treatment Period\]
COMPLETED
PHASE2
10 participants
through Day 30 Follow-up Period
2013-06-04
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
Baseline characteristics by cohort
| Measure |
Nitric Oxide Via GeNO Nitrosyl System
n=10 Participants
Nitric Oxide via GeNO Nitrosyl System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
51 years
STANDARD_DEVIATION 15.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through Day 30 Follow-up PeriodAdverse Event Severity \[through Day 30 Follow-Up Period\] Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms \[through discharge from Treatment Period\] Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin. \[through discharge from Treatment Period\] Vital Signs: pulse, blood pressure, respiratory rate \[through discharge from Treatment Period\]
Outcome measures
| Measure |
Nitric Oxide Via GeNO Nitrosyl System
n=10 Participants
Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
|
|---|---|
|
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.
|
0 participants
|
PRIMARY outcome
Timeframe: through Treatment PeriodOutcome measures
| Measure |
Nitric Oxide Via GeNO Nitrosyl System
n=10 Participants
Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
|
|---|---|
|
Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation
|
10 participants
|
Adverse Events
Nitric Oxide Via GeNO Nitrosyl System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60