Barrett's esophagus Barrett's dysplasia Cryoablation Cryotherapy Barrett slokdarm Barrett neoplasie Cryoablatie Cryotherapie
Conditions
Interventions
Patients with a Barrett's esophagus will be treated with the CryoBalloon 180 Ablation System. This includes a first treatment covering 50% of the esophageal circumference and over a length of 3 cm in
Sponsors
C2 Therapeutics, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as: - Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR - Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion or limited submucosal invasion (SM1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated) 2. Prague Classification Score C≤3 and ≥M1 3. Patients should be ablation-naïve (no previous ablation therapy of the esophagus) 4. Older than 18 years of age at time of consent 5. Operable per institution’s standards 6. Provides written informed consent on the IRB-approved informed consent form 7. Willing and able to comply with follow-up requirements
Exclusion criteria
Exclusion criteria: 1. Esophageal stenosis preventing advancement of a therapeutic endoscope. 2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER >6 weeks prior to planned treatment under this protocol. 3. Prior ER of more than 2cm in length or >50% of the esophageal lumen circumference 4. History of locally advanced (>SM1) esophageal cancer 5. History of esophageal varices 6. Prior distal esophagectomy 7. Active esophagitis LA grade B or higher 8. Severe medical comorbidities precluding endoscopy 9. Uncontrolled coagulopathy 10. Pregnant or planning to become pregnant during period of study 11. Patient refuses or is unable to provide written informed consent 12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study 13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety will be evaluated by the incidence of Dose-related SAEs 2) Efficacy (eradication percentage as determined by the EGDAdjudication Committee plus histological evidence of eradication of BE, after circumferential treatment with the therapeutic dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of all serious and non-serious adverse events up to 30 days post-treatment 2. Post-procedure epigastric or chest pain from the cryoablation treatment (0-10 VAS score), described as the mean and median pain scores at 24 hours and seven (7) days post-procedure. 3. Efficacy, defined as the regression percentage at the first followup endoscopy (after one (1) treatment covering 50% of the esophageal circumference, with the therapeutic dose) 4. Efficacy of treatment with CryoBalloon 180 Ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 semi-circumferential and after fully circumferential treatment. | — |
Contacts
Public ContactAnouk Overwater
St. Antonius Hospital Nieuwegein and University Medical Center Utrecht
Outcome results
None listed