Barrett's Esophagus, Esophageal Squamous Dysplasia, Esophageal Cancer
Conditions
Keywords
barrett's esophagus with dysplasia, early esophageal cancer
Brief summary
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).
Detailed description
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).
Interventions
DEVICECryoBalloon
Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Sponsors
Pentax Medical
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.
Exclusion criteria
* Patient unable to undergo endoscopy, * Patients with visible esophageal mass.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Eradication of Esophageal Dysplasia | 12 months | Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia). |
| Treatment-related Adverse Events Assessed by Pain Scale | 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31) | 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. |
| Treatment-related Adverse Events Assessed by Stricture Rate | Up to 12 months | Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Eradication of Intestinal Metaplasia | 12 months | Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
5 subjects were determined ineligible with index endoscopy finding exclusions, strictures restricting therapeutic scope or invasive disease.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 2 participants with protocol deviations didn't complete | 2 |
Baseline characteristics
| Characteristic | CryoBalloon Ablation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 39 Participants | — |
| Age, Categorical Between 18 and 65 years | 14 Participants | — |
| Age, Continuous | 64.7 years STANDARD_DEVIATION 1 | — |
| Likert 11 Point Pain Score (0 no pain-10 worst) | 0 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 53 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 45 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 9 / 53 |
Outcome results
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).
Time frame: 12 months
Population: 51 assessable adult patients with data collected at 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CryoBalloon Ablation | Number of Participants With Complete Eradication of Esophageal Dysplasia | 51 Participants |
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.
Time frame: 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CryoBalloon Ablation | Treatment-related Adverse Events Assessed by Pain Scale | Likert Pain score at 1 day post each cryoablation treatment | 1 units on a scale |
| CryoBalloon Ablation | Treatment-related Adverse Events Assessed by Pain Scale | Likert Pain score at 1 week post each cryoablation treatment | 0 units on a scale |
| CryoBalloon Ablation | Treatment-related Adverse Events Assessed by Pain Scale | Likert Pain score at 1 month post each (day 31 post each cryoablation treatment | 0 units on a scale |
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.
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CryoBalloon Ablation | Treatment-related Adverse Events Assessed by Stricture Rate | 6 Participants |
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
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CryoBalloon Ablation | Number of Participants With Complete Eradication of Intestinal Metaplasia | 35 Participants |