Barrett's Esophagus
Conditions
Keywords
Barrett's, high grade dysplasia, ablation, cyrotherapy
Brief summary
This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.
Interventions
DEVICECryoBalloon Focal Ablation
Sponsors
Pentax Medical
Mayo Clinic
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
* Age \> 18 years old * Able to provide informed consent * Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection,
Exclusion criteria
* Age younger than 18 years old * Presence of esophageal varices * Esophageal stricture precluding passage of an endoscope * Inability to provide informed consent * Esophageal cancer (T2 and above) * Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000 * Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication of Barrett's Esophagus | 3 months post Cryoballon Focal Ablation | Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Focal Cryo Ablation Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
CryoBalloon Focal Ablation | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 3 |
Baseline characteristics
| Characteristic | Focal Cryo Ablation | — |
|---|---|---|
| Age, Continuous | 67.94 years STANDARD_DEVIATION 7.99 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 18 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Eradication of Barrett's Esophagus
Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation
Time frame: 3 months post Cryoballon Focal Ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Focal Cryo Ablation | Eradication of Barrett's Esophagus | 2 Participants |