Trial Outcomes & Findings for Cryo Balloon for Residual Barrett's Esophagus (NCT NCT02230410)
NCT ID: NCT02230410
Last Updated: 2022-02-10
Results Overview
Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
3 months post Cryoballon Focal Ablation
Results posted on
2022-02-10
Participant Flow
Participant milestones
| Measure |
Focal Cryo Ablation
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Focal Cryo Ablation
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation
|
|---|---|
|
Overall Study
Screen Failure
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Focal Cryo Ablation
n=18 Participants
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation
|
|---|---|
|
Age, Continuous
|
67.94 years
STANDARD_DEVIATION 7.99 • n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 3 months post Cryoballon Focal AblationNumber of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation
Outcome measures
| Measure |
Focal Cryo Ablation
n=15 Participants
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation
|
|---|---|
|
Eradication of Barrett's Esophagus
|
2 Participants
|
Adverse Events
Focal Cryo Ablation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Focal Cryo Ablation
n=18 participants at risk
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation
|
|---|---|
|
Gastrointestinal disorders
Difficulty Swallowing
|
5.6%
1/18 • Adverse events were collected from baseline to end of study for a total of approximately 3 months on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place