Back to results

Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Primary Purpose

Barrett's Esophagus

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

C2 CryoBalloon Focal Ablation System

About this trial

This is an interventional treatment trial for Barrett's Esophagus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Criteria Inclusion Criteria

Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
Patient is 18 to 80 years of age at the time of consent (inclusive).
Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
Patient is deemed operable per standard institutional criteria.
BE lesion length <6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
BE lesion within the treatment zone should be flat

Exclusion Criteria

Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
Patient refuses or is unable to provide written informed consent.
Patients that are pregnant.
Patient with endoscopically active inflammation in the treatment zone.
Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.

Sites / Locations

Academic Medical Center Amsterdam
St. Antonius Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C2 CryoBalloon Focal Ablation System

Arm Description

Cryoballoon ablation will be performed on patients with Barrett's Esophagus.

Outcomes

Primary Outcome Measures

Presence of residual Barrett's Esophagus

Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation

Secondary Outcome Measures

Incidence of adverse events

All adverse events will be reported

Patient Pain

Patient is asked to rate any pain in the treatment area or with swallowing

Device Performance

All device performance will be reported

Full Information

NCT ID

NCT02249975

First Posted

September 24, 2014

Last Updated

April 21, 2022

Sponsor

Pentax Medical

1. Study Identification

Unique Protocol Identification Number

NCT02249975

Brief Title

Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Official Title

Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 29, 2016 (Actual)

Study Completion Date

October 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pentax Medical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

Detailed Description

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm. At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol. This study is: Prospective Multi-center Non-randomized

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett's Esophagus

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C2 CryoBalloon Focal Ablation System

Arm Type

Experimental

Arm Description

Cryoballoon ablation will be performed on patients with Barrett's Esophagus.

Intervention Type

Device

Intervention Name(s)

C2 CryoBalloon Focal Ablation System

Intervention Description

The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken. Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following: Device malfunctions Adverse events Patient Pain Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.

Primary Outcome Measure Information:

Title

Presence of residual Barrett's Esophagus

Description

Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Description

All adverse events will be reported

Time Frame

12 weeks

Title

Patient Pain

Description

Patient is asked to rate any pain in the treatment area or with swallowing

Time Frame

post-procedure through 12 week follow-up

Title

Device Performance

Description

All device performance will be reported

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Criteria Inclusion Criteria Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed. Patient is 18 to 80 years of age at the time of consent (inclusive). Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements. Patient is deemed operable per standard institutional criteria. BE lesion length <6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0. One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii) BE lesion within the treatment zone should be flat Exclusion Criteria Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone. Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines. Patient refuses or is unable to provide written informed consent. Patients that are pregnant. Patient with endoscopically active inflammation in the treatment zone. Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques Bergman, MD, PhD

Organizational Affiliation

Academic Medical Centre (Amsterdam)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Academic Medical Center Amsterdam

City

Amsterdam

Country

Netherlands

Facility Name

St. Antonius Hospital

City

Nieuwegein

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21531411

Citation

Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.

Results Reference

result

PubMed Identifier

29928869

Citation

van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman JJGHM, Weusten BLAM. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19.

Results Reference

derived

Learn more about this trial

Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

We'll reach out to this number within 24 hrs