C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
Netherlands30 participantsStarted 2023-01-16
Plain-language summary
The primary objective is to determine the safety, performance and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in treatment naĂŻve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
✓. Prague Classification Score C≤3 and ≥M1
âś“. Patients should be ablation-naĂŻve (no previous ablation therapy of the esophagus)
âś“. Older than 18 years of age at time of consent
âś“. Operable per institution's standards
âś“. Patient provides written informed consent on the IRB-approved informed consent form
âś“. Patient is willing and able to comply with follow-up requirements.
Exclusion criteria
âś•. Esophageal stenosis preventing advancement of a therapeutic endoscope
âś•. 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.
âś•. Prior ER of more than 2cm in length or \>50% of the esophageal lumen circumference
âś•. History of locally advanced (\>SM1) esophageal cancer