Trial Outcomes & Findings for Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium (NCT NCT02729753)
NCT ID: NCT02729753
Last Updated: 2022-04-22
Results Overview
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
2 weeks
Results posted on
2022-04-22
Participant Flow
Patients scheduled for esophagectomy for esophageal cancer or other indications unrelated to the objective of this study were approached to allow for use of cryoballoon ablation in area to be resected prior to surgery.
Participant milestones
| Measure |
CryoBalloon™ Full Ablation System
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon Swipe Ablation System
To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
CryoBalloon™ Full Ablation System
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon Swipe Ablation System
To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
Overall Study
Device Malfunction. No units in stock.
|
0
|
1
|
Baseline Characteristics
Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
Baseline characteristics by cohort
| Measure |
CryoBalloon™ Swipe Ablation System
n=6 Participants
To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon™ Full Ablation System
n=3 Participants
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
57 years
n=107 Participants
|
64 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
BMI
|
26.3 kg/m^2
n=99 Participants
|
23.3 kg/m^2
n=107 Participants
|
26 kg/m^2
n=206 Participants
|
|
History of GERD
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
History of Barrett's Esophagus
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksNumber of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Outcome measures
| Measure |
CryoBalloon™ Swipe Ablation System
n=6 Participants
To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon™ Full Ablation System
n=3 Participants
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
Safety of the CryoBalloon™ Full and Swipe Ablation System
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Submucosal evaluation done for patients at differing doses.
Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment. Dose response by effect of ablation to submucosa: 0: Normal 1. Inflammatory cell infiltration 2. Separation with inflammation 3. Edema and Necrosis
Outcome measures
| Measure |
CryoBalloon™ Swipe Ablation System
n=3 Participants
To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon™ Full Ablation System
n=6 Participants
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
0.6mm/sec : Immediate esophagectomy
|
1 units on a scale
|
2 units on a scale
|
|
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
0.5mm/sec : Immediate esophagectomy
|
2 units on a scale
|
0 units on a scale
|
|
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
0.5mm/sec : Esophagectomy 5 days Post
|
3 units on a scale
|
1 units on a scale
|
|
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
0.8mm/sec :Immediate esophagectomy
|
—
|
2 units on a scale
|
|
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
0.8mm/sec : Esophagectomy 5 days Post
|
—
|
1 units on a scale
|
|
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
0.9mm/sec : Immediate esophagectomy
|
—
|
1 units on a scale
|
SECONDARY outcome
Timeframe: Minutes from start to end of procedureAverage Procedure time as measured from start to finish of ablation.
Outcome measures
| Measure |
CryoBalloon™ Swipe Ablation System
n=3 Participants
To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon™ Full Ablation System
n=6 Participants
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
Device Performance: Average Procedure Time
|
5 Minutes
Interval 5.0 to 5.0
|
4.8 Minutes
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Minutes, from start to end of procedurePopulation: CryoBalloon Full and Swipe Ablation Systems used by physicians to perform ablation
Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)
Outcome measures
| Measure |
CryoBalloon™ Swipe Ablation System
n=3 Participants
To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon™ Full Ablation System
n=6 Participants
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
Device Performance: Ease of Deployment of Device
|
9 units on a scale
Interval 9.0 to 9.0
|
7.8 units on a scale
Interval 7.0 to 9.0
|
Adverse Events
CryoBalloon™ Full Ablation System
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CryoBalloon™ Swipe Ablation System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CryoBalloon™ Full Ablation System
n=3 participants at risk
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
CryoBalloon™ Swipe Ablation System
n=6 participants at risk
To evaluate CryoBalloon™ Full Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
|
|---|---|---|
|
General disorders
Post Procedure Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place