Esophageal Cancer
Conditions
Brief summary
This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study
Detailed description
The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.
Interventions
DEVICECryoBalloon™ Full Ablation System
Tissue Ablation using CryoBalloon™ Full Ablation System
DEVICECryoBalloon™ Swipe Ablation System
Tissue Ablation using CryoBalloon™ Swipe Ablation System
Sponsors
Pentax Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation * Older than 18 years of age * Requires a clinically necessary esophagectomy for esophageal cancer or other indications.
Exclusion criteria
* Patient has esophageal narrowing limiting access to the intended sites of ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the CryoBalloon™ Full and Swipe Ablation System | 2 weeks | Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System |
| Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems | 2 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance: Average Procedure Time | Minutes from start to end of procedure | Average Procedure time as measured from start to finish of ablation. |
| Device Performance: Ease of Deployment of Device | Minutes, from start to end of procedure | Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device Malfunction. No units in stock. | 0 | 1 |
Baseline characteristics
| Characteristic | Total | CryoBalloon™ Swipe Ablation System | CryoBalloon™ Full Ablation System |
|---|---|---|---|
| Age, Continuous | 64 years | 69 years | 57 years |
| BMI | 26 kg/m^2 | 26.3 kg/m^2 | 23.3 kg/m^2 |
| History of Barrett's Esophagus | 4 Participants | 4 Participants | 0 Participants |
| History of GERD | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 2 Participants |
| Region of Enrollment Netherlands | 3 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 6 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 6 |
| other Total, other adverse events | 1 / 3 | 0 / 6 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 |
Outcome results
Primary
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
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
Time frame: 2 weeks
Population: Submucosal evaluation done for patients at differing doses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CryoBalloon™ Swipe Ablation System | 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 |
| CryoBalloon™ Swipe Ablation System | 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 |
| CryoBalloon™ Swipe Ablation System | 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 |
| CryoBalloon™ Full Ablation System | 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 | 1 units on a scale |
| CryoBalloon™ Full Ablation System | 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 |
| CryoBalloon™ Full Ablation System | Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems | 0.6mm/sec : Immediate esophagectomy | 2 units on a scale |
| CryoBalloon™ Full Ablation System | 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 |
| CryoBalloon™ Full Ablation System | Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems | 0.5mm/sec : Immediate esophagectomy | 0 units on a scale |
| CryoBalloon™ Full Ablation System | 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 |
Primary
Safety of the CryoBalloon™ Full and Swipe Ablation System
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CryoBalloon™ Swipe Ablation System | Safety of the CryoBalloon™ Full and Swipe Ablation System | 0 Participants |
| CryoBalloon™ Full Ablation System | Safety of the CryoBalloon™ Full and Swipe Ablation System | 0 Participants |
Secondary
Device Performance: Average Procedure Time
Average Procedure time as measured from start to finish of ablation.
Time frame: Minutes from start to end of procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CryoBalloon™ Swipe Ablation System | Device Performance: Average Procedure Time | 5 Minutes |
| CryoBalloon™ Full Ablation System | Device Performance: Average Procedure Time | 4.8 Minutes |
Secondary
Device Performance: Ease of Deployment of Device
Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)
Time frame: Minutes, from start to end of procedure
Population: CryoBalloon Full and Swipe Ablation Systems used by physicians to perform ablation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CryoBalloon™ Swipe Ablation System | Device Performance: Ease of Deployment of Device | 9 units on a scale |
| CryoBalloon™ Full Ablation System | Device Performance: Ease of Deployment of Device | 7.8 units on a scale |