Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus

Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus

The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus
• Intervention / Treatment: Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • AMC Medical Research B.V.
  • Amsterdam, Netherlands
    • St. Antonius Hospital Nieuwegein
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis te Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Prague Classification Score C≤3
3. Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
4. Older than 18 years of age at time of consent
5. Operable 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 or stricture preventing advancement of a therapeutic endoscope.
2. Any endoscopically visualized lesion such as ulcers, masses or nodules.
3. History of locally advanced (>T1a) esophageal cancer
4. History of esophageal varices
5. Prior distal esophagectomy
6. Active esophagitis LA grade B or higher
7. Severe medical comorbidities precluding endoscopy
8. Uncontrolled coagulopathy
9. Pregnant or planning to become pregnant during period of study
10. Patient refuses or is unable to provide written informed consent
11. Participation in another study with investigational drug within the 30 days preceding or during the present study
12. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: C2 Cryoballoon Swipe Ablation System	Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
Efficacy: Percent Eradication by therapeutic dose	Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs	Incidence of all serious and non-serious adverse events up to 30 days post-treatment.	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)	24 hours and 7 days post-procedure
Efficacy: Percent Regression	Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.	8 weeks
Efficacy: Treatment	Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Pentax Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: CP-0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared.

Drug and device information, study documents

• 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