Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
Primary Purpose
Barrett Esophagus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
C2 CRYOBALLOON SWIPE ABLATION SYSTEM
Sponsored by
About this trial
This is an interventional treatment trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria:
Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
- Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
- Residual BE with any grade of dysplasia after endoscopic resection
- Prague Classification Score C≤3
- Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
- Older than 18 years of age at time of consent
- Operable 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 or stricture preventing advancement of a therapeutic endoscope.
- Any endoscopically visualized lesion such as ulcers, masses or nodules.
- History of locally advanced (>T1a) 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
- Patient refuses or is unable to provide written informed consent
- Participation in another study with investigational drug within the 30 days preceding or during the present study
- General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Sites / Locations
- AMC Medical Research B.V.
- St. Antonius Hospital Nieuwegein
- Catharina Ziekenhuis te Eindhoven
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
C2 Cryoballoon Swipe Ablation System
Arm Description
C2 Cryoballoon Swipe Ablation System
Outcomes
Primary Outcome Measures
Dose-related SAEs
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Efficacy: Percent Eradication by therapeutic dose
Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Secondary Outcome Measures
Incidence of AEs
Incidence of all serious and non-serious adverse events up to 30 days post-treatment.
Post-procedure pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10 point VAS)
Efficacy: Percent Regression
Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.
Efficacy: Treatment
Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03097666
Brief Title
Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
Official Title
Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pentax Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
Detailed Description
The procedure will be performed on an outpatient basis, and the CryoBalloon Swipe will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 6 patients will be treated with Dose 1 (lowest).
All patients will have to undergo 8 week (±1 week) follow-up EGD to evaluate efficacy of the dose before the study continues.
If the follow-up endoscopies show that Dose 1 eradicates ≥80% of the treated BE (by median percentage) and no SAE's are reported, this dose is defined as the therapeutic dose and enrollment will proceed to phase II.
If Dose 1 eradicates <80% of the treated BE, enrollment in Phase I will continue at the next highest dose. Treatment doses will be escalated in this manner until the earlier of a dose-related Serious Adverse Event (SAE) or determination of the therapeutic dose based on endoscopic exam.
When the therapeutic dose is determined, the study will proceed to Phase II to generate additional safety and efficacy data.
Phase II
Phase II will confirm the safety and efficacy of the therapeutic dose found in Phase I.
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Dose-related SAEs include pain in the treatment area greater than 6 (on VAS) on 24 hours and seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity.
When a Dose-related serious adverse event occurs, the Holding Rule will be invoked and enrollment at that dose will be held until the DSMB has evaluated the event.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after removal of early adenocarcinoma
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C2 Cryoballoon Swipe Ablation System
Arm Type
Other
Arm Description
C2 Cryoballoon Swipe Ablation System
Intervention Type
Device
Intervention Name(s)
C2 CRYOBALLOON SWIPE ABLATION SYSTEM
Intervention Description
The C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes.
Primary Outcome Measure Information:
Title
Dose-related SAEs
Description
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time Frame
30 days
Title
Efficacy: Percent Eradication by therapeutic dose
Description
Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Incidence of AEs
Description
Incidence of all serious and non-serious adverse events up to 30 days post-treatment.
Time Frame
up to 30 days post-treatment
Title
Post-procedure pain
Description
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10 point VAS)
Time Frame
24 hours and 7 days post-procedure
Title
Efficacy: Percent Regression
Description
Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.
Time Frame
8 weeks
Title
Efficacy: Treatment
Description
Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
Residual BE with any grade of dysplasia after endoscopic resection
Prague Classification Score C≤3
Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
Older than 18 years of age at time of consent
Operable 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 or stricture preventing advancement of a therapeutic endoscope.
Any endoscopically visualized lesion such as ulcers, masses or nodules.
History of locally advanced (>T1a) 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
Patient refuses or is unable to provide written informed consent
Participation in another study with investigational drug within the 30 days preceding or during the present study
General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Facility Information:
Facility Name
AMC Medical Research B.V.
City
Amsterdam
Country
Netherlands
Facility Name
St. Antonius Hospital Nieuwegein
City
Amsterdam
Country
Netherlands
Facility Name
Catharina Ziekenhuis te Eindhoven
City
Eindhoven
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared.
Learn more about this trial
Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
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