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

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

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

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 days

Population: study terminated by Sponsor-data not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: 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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place