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CBAS180 De-escalation Study

Primary Purpose

Barrett's Esophagus, Ablation Therapy, Cryotherapy

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
C2 CryoBalloon 180° Ablation System
Sponsored by
Koen Munters
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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). Prague Classification Score of C≤3 and M≥1. Patients should be ablation-naïve, meaning they have not undergone any previous endoscopic 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 Criteria: Esophageal stenosis preventing advancement of a therapeutic endoscope. 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. 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.

Sites / Locations

  • Catharina Hospital
  • Amsterdam UMC
  • St Antonius hospitalRecruiting
  • Erasmus MC
  • UMC Groningen
  • UMC Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C2 CryoBalloon 180 Ablation System

Arm Description

C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus

Outcomes

Primary Outcome Measures

Efficacy: Dose response
Efficacy (dose response) will be evaluated by the BE surface regression percentage after 1 circumferential treatment session, as evaluated by the EGD-Adjudication Committee (EGD-AC) and confirmed by histological evidence of eradication of BE.
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 24 hours post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 7 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 30 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.

Secondary Outcome Measures

Feasibility: technical succes
Feasibility (technical success) defined as the percentage of patients in whom all BE could be treated as intended by the treating endoscopist.
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score directly after treatment.
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 1 day after treatment.
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 7 days after treatment.
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 30 days after treatment.
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score directly after treatment.
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 1 day after treatment.
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 7 days after treatment.
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 30 days after treatment.
Incidence AE and SAE
Incidence of all serious and non-serious AEs up to 30 days post-treatment.
BE regression
BE surface regression percentage after 1 circumferential treatment session as assessed by the treating endoscopist.

Full Information

First Posted
January 18, 2023
Last Updated
February 13, 2023
Sponsor
Koen Munters
Collaborators
Pentax Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05740189
Brief Title
CBAS180 De-escalation Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Koen Munters
Collaborators
Pentax Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Ablation Therapy, Cryotherapy, Cryoballoon Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C2 CryoBalloon 180 Ablation System
Arm Type
Experimental
Arm Description
C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus
Intervention Type
Device
Intervention Name(s)
C2 CryoBalloon 180° Ablation System
Intervention 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.
Primary Outcome Measure Information:
Title
Efficacy: Dose response
Description
Efficacy (dose response) will be evaluated by the BE surface regression percentage after 1 circumferential treatment session, as evaluated by the EGD-Adjudication Committee (EGD-AC) and confirmed by histological evidence of eradication of BE.
Time Frame
3 months
Title
Safety: Incidence of Dose-related SAEs
Description
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 24 hours post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time Frame
24hours
Title
Safety: Incidence of Dose-related SAEs
Description
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 7 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time Frame
7 days
Title
Safety: Incidence of Dose-related SAEs
Description
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 30 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Feasibility: technical succes
Description
Feasibility (technical success) defined as the percentage of patients in whom all BE could be treated as intended by the treating endoscopist.
Time Frame
Directly after procedure
Title
Post-procedural pain
Description
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score directly after treatment.
Time Frame
Directly after procedure
Title
Post-procedural pain
Description
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 1 day after treatment.
Time Frame
24 hours
Title
Post-procedural pain
Description
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 7 days after treatment.
Time Frame
7 days
Title
Post-procedural pain
Description
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 30 days after treatment.
Time Frame
30 days
Title
Post-procedure dysphagia
Description
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score directly after treatment.
Time Frame
Directly after procedure
Title
Post-procedure dysphagia
Description
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 1 day after treatment.
Time Frame
24 hours
Title
Post-procedure dysphagia
Description
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 7 days after treatment.
Time Frame
7 days
Title
Post-procedure dysphagia
Description
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 30 days after treatment.
Time Frame
30 days
Title
Incidence AE and SAE
Description
Incidence of all serious and non-serious AEs up to 30 days post-treatment.
Time Frame
30 days
Title
BE regression
Description
BE surface regression percentage after 1 circumferential treatment session as assessed by the treating endoscopist.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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). Prague Classification Score of C≤3 and M≥1. Patients should be ablation-naïve, meaning they have not undergone any previous endoscopic 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 Criteria: Esophageal stenosis preventing advancement of a therapeutic endoscope. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Munters, Msc
Phone
088-7559682
Email
k.munters-3@umcutrecht.nl
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Schoon, Prof. dr.
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Bergman, Prof. dr.
Facility Name
St Antonius hospital
City
Nieuwegein
State/Province
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bas Weusten, Prof. dr.
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjun Koch, Dr.
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Nagengast, Prof. dr.
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bas Weusten, Prof. dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CBAS180 De-escalation Study

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