Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CryoBalloon™ Full Ablation System | Other | 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 | Other | To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CryoBalloon™ Full Ablation System | Device | Tissue Ablation using CryoBalloon™ Full Ablation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| 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
| 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance: Average Procedure Time | Average Procedure time as measured from start to finish of ablation. | Minutes from start to end of procedure |
| Device Performance: Ease of Deployment of Device |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Louie, MD | Swedish Medical Center and Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Swedish Medical Center and Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | CryoBalloon™ Full Ablation System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 2 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Procedure Pain | General disorders | Non-systematic Assessment | Patient experienced pain score of 3 on VAS scale 0 - 10, 24 hours post procedure. |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcia Wachna, Director of Clinical Research | C2 Therapeutics | marcia@c2therapeutics.com |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CryoBalloon™ Swipe Ablation System | Device | Tissue Ablation using CryoBalloon™ Swipe Ablation System |
|
|
Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)
| Minutes, from start to end of procedure |
| Seattle |
| Washington |
| 98122 |
| United States |
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| History of GERD | Count of Participants | Participants |
|
| History of Barrett's Esophagus | Count of Participants | Participants |
|
|
|
| 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
| Submucosal evaluation done for patients at differing doses. | Posted | Number | units on a scale | 2 weeks |
|
|
|
| Secondary | Device Performance: Average Procedure Time | Average Procedure time as measured from start to finish of ablation. | Posted | Mean | Full Range | Minutes | Minutes from start to end of procedure |
|
|
|
| Secondary | Device Performance: Ease of Deployment of Device | Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best) | CryoBalloon Full and Swipe Ablation Systems used by physicians to perform ablation | Posted | Mean | Full Range | units on a scale | Minutes, from start to end of procedure |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
|
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| 0.5mm/sec : Esophagectomy 5 days Post |
|
|
| 0.6mm/sec : Immediate esophagectomy |
|
|
| 0.8mm/sec :Immediate esophagectomy |
|
|
| 0.8mm/sec : Esophagectomy 5 days Post |
|
|
| 0.9mm/sec : Immediate esophagectomy |
|
|