Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett*s epithelium.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Efficacy defined as the median BE surface regression percentage after 1
circumferential treatment session, as evaluated by the EGD-Adjudication
Committee and confirmed by histological evidence of eradication of BE.
2) Safety defined as the incidence of dose-related serious adverse events.
Secondary outcome
1) Feasibility (technical success) defined as the percentage of patients in
whom all BE could be treated as intended by the treating endoscopist.
2) Post-procedure pain in the area of the cryoablation treatment (0-10 NRS),
described as the median pain scores directly, 1, 7 and 30 days after treatment.
3) Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the
median dysphagia scores directly, 1, 7 and 30 days after treatment.
4) Incidence of all serious and non-serious AEs up to 30 days post-treatment.
5) Median BE surface regression percentage after 1 circumferential treatment
session as assessed by the treating endoscopist.
Background summary
Cryoballoon ablation is a relatively new ablation technique for the treatment
of dysplastisch 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.
Study objective
Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem
(CBAS180) at decremental doses for the treatment of dysplastic Barrett*s
epithelium.
Study design
Multicenter, prospective, non-randomized, intervention study.
Intervention
Circumferential ablation of 3cm of length of Barrett*s epithelium using the
CBAS180 at decremental dosages during an upper endoscopy.
Study burden and risks
The nature and extent of the burden and risks associated with study
participation are minimal. Preliminary results of the CBAS180 have shown good
efficacy and safety. Since we only slightly lower the doses for the current
study in comparison to previous studies, we do not have concerns regarding
efficacy or safety. We do not anticipate that patients will require more
treatment sessions or be exposed to a higher complication risk compared to
current standard of care, radiofrequency ablation. On the contrary,
cryoablation is thought to preserve the extracellular matrix, which may result
in less pain and lower stricture rates and therefore better patient
tolerability.
Paragon Drive Montvale 3
New Jersey 07645-1782
US
Paragon Drive Montvale 3
New Jersey 07645-1782
US
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05740189 |
| CCMO | NL73252.000.22 |