CBAS180 De-escalation Study

Status Recruiting

Clinical Trial Summary

Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.

Clinical Trial Description

Cryoballoon ablation is a relatively new ablation technique for the treatment of dysplastic Barrett's esophagus (BE). Previous studies with this technique have shown that treatment is safe and effective. When compared to other ablation techniques, cryoballon ablation has several potential advantages, including less pain and less complications such as stricture formation after treatment. Recently, a cryoballoon ablation system has become available which enables treatment of larger esophageal surfaces. Although a recent clinical study with this new device has shown promising results, the lowest possible dose that optimally balances safety and efficacy is still unknown. This study is a multicenter, prospective, intervention study consisting of two phases: the treatment phase and the follow-up phase. During the treatment phase, patients will undergo an upper endoscopy during which CBAS180 treatment will be performed. Treatment consists of two CBAS180 applications, starting just below the gastroesophageal junction (GEJ), resulting in a circumferential ablation of 3cm in length. During the treatment phase, two doses will be tested consecutively starting with the lowest dose (i.e. 1.2mm/sec). For each dose a total of 25 patients will be included. An interim analysis will be performed after treatment of the first 25 patients with the lowest dose of 1.2mm/sec, before proceeding to treatment of the additional 25 patients with a higher dose of 1.1mm/sec. The follow-up phase starts after CBAS180 treatment and ends after first follow-up endoscopy at 10 weeks (±2 weeks) after treatment. Therefore, the study duration will be approximately 3 months for each individual patient. The investigators expect to report the primary outcome for all participating patients within 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05740189
Study type	Interventional
Source	St. Antonius Hospital
Contact	Koen Munters, Msc
Phone	088-7559682
Email	k.munters-3@umcutrecht.nl
Status	Recruiting
Phase	N/A
Start date	February 19, 2023
Completion date	January 15, 2026

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02864043` - Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System	N/A
Recruiting	`NCT02018367` - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma	Phase 2
Terminated	`NCT01572987` - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus	N/A
Terminated	`NCT01976351` - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus	N/A
Terminated	`NCT00526786` - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus	Phase 4
Completed	`NCT01401699` - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction	N/A
Completed	`NCT02106910` - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy	N/A
Suspended	`NCT01580631` - Narrow Band Imaging Project on Barrett's Esophagus
Completed	`NCT01439633` - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus	N/A
Completed	`NCT02879721` - Expression and Function of the Renin-Angiotensin System in the Esophagus	Phase 0
Completed	`NCT01281618` - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus	N/A
Completed	`NCT01439594` - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation	N/A
Completed	`NCT00586872` - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed	`NCT00844077` - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus	N/A
Completed	`NCT00588575` - Ramanspectroscopy in Barrett's Esophagus
Recruiting	`NCT00288119` - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed	`NCT02579460` - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition	N/A
Completed	`NCT03813381` - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).	N/A
Not yet recruiting	`NCT02033070` - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System	N/A
Completed	`NCT01961778` - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.