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This is a feasibility study without a primary study hypothesis or statistical comparison.
The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken.
Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.
Evaluations include, but are not limited to the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. |
| |
| Cohort B | Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. |
| |
| Cohort C | Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal Cryoballoon Ablation System - 6 seconds | Device | Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal Stricture | Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope). | 6 to 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure pain relative | A secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale (0 to 10). Patients is asked to score pain level in the treatment area and swallowing. | Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Barrett's esophagus with or without dysplasia
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| Name | Affiliation | Role |
|---|---|---|
| Bas L Weusten, MD, pHD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| John Hopkins |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21531411 | Background | Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Focal Cryoballoon Ablation System - 8 seconds | Device | Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. 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." |
|
| CryoBalloon Focal Ablation System - 10 seconds | Device | Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. 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". |
|
| Presence of Residual Barrett's Esophagus |
Esophageal tissue subjected to ablation via the CryoBalloon Focal Ablation System will be submitted for histological evaluation. The evaluation will include:
|
| 6 to 8 weeks |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Columbia Medical Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Academic Medical Center Amsterdam | Amsterdam | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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