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The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon Ablation | Device | Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." (K101825) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment effect | The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system. | Within 30 days of ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ablation symptoms | A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability. | Within 7 days of ablation procedure |
| Post procedure pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Bergman, MD | AIDS Malignancy Consortium | Principal Investigator |
| Steve DeMeester, MD | University of Southern California | Principal Investigator |
| Blair Jobe, MD | University of Pittsburgh | Principal Investigator |
| Jeffery Peters, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of Rochester |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.
| Within 7 days of ablation procedure |
| Rochester |
| New York |
| 14642 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| AMC | Amsterdam | AZ | 1105 | Netherlands |
| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |