Clinical trial to evaluate safety and efficacy of the C2 CryoBalloon 180° Ablation System for the treatment of dysplastic Barrett*s esophagus: CBAS180 de-escalation study

Recruiting

• Conditions: Barrett's esophagus; Barrett's neoplasia; 10017990

• Registration Number: NL-OMON52660
• Lead Sponsor: Pentax Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 122

Inclusion Criteria

1) Flat type BE esophagus, with an indication for ablation therapy, defined as:
a) Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
b) 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 of C<=3 and M>=1.
3) Patients should be ablation-naïve, meaning they have not undergone any
previous endoscopic ablation therapy of the esophagus.
4) Older than 18 years of age at time of consent.
5) Fit for endoscopic therapy 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

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 >2cm in length and/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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Efficacy defined as the median BE surface regression percentage after 1<br /><br>circumferential treatment session, as evaluated by the EGD-Adjudication<br /><br>Committee and confirmed by histological evidence of eradication of BE.<br /><br>2) Safety defined as the incidence of dose-related serious adverse events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Feasibility (technical success) defined as the percentage of patients in<br />whom all BE could be treated as intended by the treating endoscopist.<br />2) Post-procedure pain in the area of the cryoablation treatment (0-10 NRS),<br />described as the median pain scores directly, 1, 7 and 30 days after treatment.<br />3) Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the<br />median dysphagia scores directly, 1, 7 and 30 days after treatment.<br />4) Incidence of all serious and non-serious AEs up to 30 days post-treatment.<br />5) Median BE surface regression percentage after 1 circumferential treatment<br />session as assessed by the treating endoscopist. </p>