Phase
Condition
Barrett's Esophagus
Heartburn
Esophageal Disorders
Treatment
C2 CryoBalloon 180° Ablation System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Flat type BE esophagus, with an indication for ablation therapy, defined as:
Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
Residual BE with any grade of dysplasia after endoscopic resection (by means ofEMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient tothis study. The ER pathology should indicate endoscopic treatment (i.e. onlymucosal invasion or limited submucosal invasion (sm1), no lymphovascularinfiltration, free vertical resection margins and not poorly differentiated).
Prague Classification Score of C≤3 and M≥1.
Patients should be ablation-naïve, meaning they have not undergone any previousendoscopic ablation therapy of the esophagus.
Older than 18 years of age at time of consent.
Fit for endoscopic therapy per institution's standards.
Provides written informed consent on the IRB-approved informed consent form.
Willing and able to comply with follow-up requirements.
Exclusion
Exclusion Criteria:
Esophageal stenosis preventing advancement of a therapeutic endoscope.
Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplasticnodules must first be treated with ER ≥6 weeks prior to planned treatment under thisprotocol.
Prior ER of >2cm in length and/or >50% of the esophageal lumen circumference.
History of locally advanced (>sm1) esophageal cancer.
History of esophageal varices.
Prior distal esophagectomy.
Active esophagitis LA grade B or higher.
Severe medical comorbidities precluding endoscopy.
Uncontrolled coagulopathy.
Pregnant or planning to become pregnant during period of study.
Study Design
Study Description
Connect with a study center
Catharina Hospital
Eindhoven, Noord-Brabant
NetherlandsActive - Recruiting
Amsterdam UMC
Amsterdam, Noord-Holland
NetherlandsActive - Recruiting
St Antonius hospital
Nieuwegein, Utrecht
NetherlandsActive - Recruiting
Erasmus MC
Rotterdam, Zuid-Holland
NetherlandsActive - Recruiting
UMC Groningen
Groningen,
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht,
NetherlandsActive - Recruiting
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