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| Name | Class |
|---|---|
| Pentax Medical | INDUSTRY |
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Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).
Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CryoBalloon ablation | Experimental | Patients having ablation of dysplastic tissue in esophagus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CryoBalloon | Device | Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Eradication of Esophageal Dysplasia | Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia). | 12 months |
| Treatment-related Adverse Events Assessed by Pain Scale | Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease. | 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31) |
| Treatment-related Adverse Events Assessed by Stricture Rate | Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Eradication of Intestinal Metaplasia | Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia Canto, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29626424 | Result | Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5. | |
| 28720474 | Result |
| Label | URL |
|---|---|
| Durability of Cryoballoon Ablation in Neoplastic Barrett's Esophagus | View source |
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5 subjects were determined ineligible with index endoscopy finding exclusions, strictures restricting therapeutic scope or invasive disease.
Individuals who are clinical patients of the Principal Investigator or Co-investigators will be identified as eligible by prior pathology proven biopsies with either Barrett's esophagus with dysplasia or esophageal squamous cell dysplasia.
Recruitment will occur primarily in the outpatient GI clinic but can also be a phone contact and follow-up study consent for review with informed consent call.
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| ID | Title | Description |
|---|---|---|
| FG000 | CryoBalloon Ablation | Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CryoBalloon Ablation | Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | eligibility criteria is age 18 years or greater |
| 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 | Number of Participants With Complete Eradication of Esophageal Dysplasia | Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia). | 51 assessable adult patients with data collected at 12 months | Posted | Count of Participants | Participants | 12 months |
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Post ablation treatment assessment day 1, 7 days, 30 days, and follow up endoscopies up to 12 months
pain (0-10 Likert pain scale,) pain requiring narcotics, dysphagia (0-4 dysphagia score), bleeding, esophageal strictures requiring dilation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CryoBalloon Ablation | Patients having ablation of dysplastic tissue in esophagus. CryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Bleeding | Gastrointestinal disorders | Systematic Assessment | Post esophageal cryoablation treatment bleeding requiring treatment |
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Prospective single arm non-randomized trial, no control subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marcia Canto, Director of Clinical Research | Johns Hopkins Hospital | 443-287-8083 | mcanto1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2019 | May 15, 2025 | Prot_SAP_000.pdf |
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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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| Canto MI, Abrams JA, Kunzli HT, Weusten B, Komatsu Y, Jobe BA, Lightdale CJ. Nitrous oxide cryotherapy for treatment of esophageal squamous cell neoplasia: initial multicenter international experience with a novel portable cryoballoon ablation system (with video). Gastrointest Endosc. 2018 Feb;87(2):574-581. doi: 10.1016/j.gie.2017.07.013. Epub 2017 Jul 16. |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Likert 11 Point Pain Score (0 no pain-10 worst) | The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain | Mean | Inter-Quartile Range | units on a scale |
|
| Participants |
|
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| Primary | Treatment-related Adverse Events Assessed by Pain Scale | Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease. | Posted | Median | Inter-Quartile Range | units on a scale | 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31) |
|
|
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| Primary | Treatment-related Adverse Events Assessed by Stricture Rate | Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months. | Posted | Count of Participants | Participants | No | Up to 12 months |
|
|
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| Secondary | Number of Participants With Complete Eradication of Intestinal Metaplasia | Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation | 41 of the 51 evaluable subjects had Barrett's esophagus (intestinal metaplasia) data collected at 12 months; this outcome measure does not apply to subjects with esophageal squamous dyplasia. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 53 |
| 9 |
| 53 |
| 0 |
| 53 |
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| post cryoablation treatment pain requiring narcotics | Gastrointestinal disorders | Systematic Assessment | subjects reporting pain requiring narcotics for pain at or between 1, 7, or 30 day follow up calls. |
|
| Esophageal stricture requiring dilation | Gastrointestinal disorders | Systematic Assessment | subject reporting 3 or 4 on dysphagia scale, unable to swallow semi solid or liquid food |
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| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
|