To hear about similar clinical trials, please enter your email below
Trial Title:
CBAS180 De-escalation Study
NCT ID:
NCT05740189
Condition:
Barrett's Esophagus
Ablation Therapy
Cryotherapy
Cryoballoon Ablation
Conditions: Official terms:
Barrett Esophagus
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
C2 CryoBalloon 180° Ablation System
Description:
The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide
cooled balloon probe that is compatible with upper gastrointestinal therapeutic
endoscopes.
Arm group label:
C2 CryoBalloon 180 Ablation System
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Flat type BE esophagus, with an indication for ablation therapy, defined as:
1. Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
2. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Catharina Hospital
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Erik Schoon, Prof. dr.
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jacques Bergman, Prof. dr.
Facility:
Name:
St Antonius hospital
Address:
City:
Nieuwegein
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Bas Weusten, Prof. dr.
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Arjun Koch, Dr.
Facility:
Name:
UMC Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Wouter Nagengast, Prof. dr.
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Bas Weusten, Prof. dr.
Start date:
February 19, 2023
Completion date:
January 15, 2026
Lead sponsor:
Agency:
Koen Munters
Agency class:
Other
Collaborator:
Agency:
Pentax Medical
Agency class:
Industry
Source:
St. Antonius Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740189
