C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.

Launched by PENTAX MEDICAL · Oct 13, 2017

Keywords

ClinConnect Summary

The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system will be used for all ablations following the instructions for use provided with the product.

Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:

In phase I, the first 25 patients will be treated with Dose 1 (lowest), in one application to ablate 50% of the esophageal circumference.

All patients will undergo 10 week (±2 weeks) follow-up EGD to evaluate efficacy of the dose before the study continues.

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Gender

ALL

Eligibility 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 6 weeks after endoscopic resection
• • 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. Patient provides written informed consent on the IRB-approved informed consent form
• • 7. Patient is willing and able to comply with follow-up requirements.
• 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