Trial Outcomes & Findings for Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD") (NCT NCT00747461)
NCT ID: NCT00747461
Last Updated: 2015-08-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
30 days
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
Cryo Spray Ablation
subjects receiving up to 4 -5 second spray cycles
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Cryo Spray Ablation
subjects receiving up to 4 -5 second spray cycles
|
|---|---|
|
Overall Study
study terminated by sponsor
|
5
|
Baseline Characteristics
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
Baseline characteristics by cohort
| Measure |
Cryo Spray Ablation
n=5 Participants
subjects will receive up to 4 -5 second cycles of cryospray ablation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: study terminated by Sponsor-data not analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: study terminated-no subjects analyzed.
need for additional treatments within specified period
Outcome measures
Outcome data not reported
Adverse Events
All Subjects Receiving CSA Cryospray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ann Murphy Legg, Director of Clinical Research
CSA Medical
Phone: 781-538-4732
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place