Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System (ColdPlayIII)

• ClinicalTrials.gov Identifier: NCT02514525
• Recruitment Status: Active, not recruiting
• First Posted: August 3, 2015
• Last Update Posted: April 22, 2022
• Sponsor: Pentax Medical
• Information provided by (Responsible Party): Pentax Medical

Study Description

Brief Summary:

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Condition or disease	Intervention/treatment	Phase
Barrett Esophagus	Device: CryoBalloon Ablation System	Not Applicable

Detailed Description:

Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
• Study Start Date: March 2016
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm

Intervention/treatment

CryoBalloon Ablation System; Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.

Device: CryoBalloon Ablation System; CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.; Other Name: CryoBalloon Focal Ablation System

Outcome Measures

Primary Outcome Measures :

1. Incidence of serious, CryoBalloon Ablation System-related adverse events [ Time Frame: 12 months ]
2. Percentage of patients with baseline LGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
3. percentage of patients with baseline HGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
4. percentage of all treated patients who have complete eradication of all dysplasia (CE-D) [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM) [ Time Frame: 12 months ]
2. Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer [ Time Frame: 12 months ]
   For Baseline LGD and HGD subjects: progression of dysplasia
3. Incidence of all treatment-related and all serious, non-treatment-related adverse events [ Time Frame: 12 months ]
4. Incidence of post procedure chest discomfort events / Pain score >0 and <5 [ Time Frame: Day 1 ]
   (scored on a 0-10 visual analog pain scale)
5. Incidence of post procedure chest discomfort events / Pain score ≥5 and requiring narcotic analgesic [ Time Frame: Day 7 ]
   (scored on a 0-10 visual analog pain scale)
6. Mean and Median Pain score on Day 1 post procedure [ Time Frame: Day 1 ]
   (scored on a 0-10 visual analog pain scale)
7. Mean and Median Pain score on Day 7 post procedure [ Time Frame: Day 7 ]
   (scored on a 0-10 visual analog pain scale)
8. Rate of (CE-D) and all esophageal (CE-IM) will be reported as a percentage of all subjects enrolled, and stratified by baseline dysplasia grade [ Time Frame: 24 and 36 months ]
9. Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM [ Time Frame: 12 months ]
   (mean and median)

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
• BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
• Older than 18 years of age at time of consent
• Operable per institution's standards
• Provides written informed consent on the approved informed consent form
• Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

• Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
• Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later)
• Symptomatic untreated strictures
• Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
• History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion)
• History of esophageal varices
• Large (>4cm) hiatal hernia
• Prior distal esophagectomy
• Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
• Active esophagitis grade B or higher
• Severe medical comorbidities precluding endoscopy
• Uncontrolled coagulopathy
• Pregnant or planning to become pregnant during period of study participation
• Patient refuses or is unable to provide written informed consent
• Life expectancy ≤3 years, as judged by the site investigator
• General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Contacts and Locations

Locations

United States, California

UC Irvine

Orange, California, United States, 92868

United States, Florida

Sarasota Memorial Hospital

Sarasota, Florida, United States, 34239

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

United States, Maryland

John Hopkins

Baltimore, Maryland, United States, 21205

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New York

Northwell Health

Manhasset, New York, United States, 11030

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States, 27599

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

United States, Pennsylvania

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Pentax Medical

Investigators

• Principal Investigator: Marcia Canto, MD; Johns Hopkins Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Canto MI, Trindade AJ, Abrams J, Rosenblum M, Dumot J, Chak A, Iyer P, Diehl D, Khara HS, Corbett FS, McKinley M, Shin EJ, Waxman I, Infantolino A, Tofani C, Samarasena J, Chang K, Wang B, Goldblum J, Voltaggio L, Montgomery E, Lightdale CJ, Shaheen NJ. Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial. Am J Gastroenterol. 2020 Nov;115(11):1879-1890. doi: 10.14309/ajg.0000000000000822.

• Responsible Party: Pentax Medical
• ClinicalTrials.gov Identifier: NCT02514525
• Other Study ID Numbers: CP-0011
• First Posted: August 3, 2015
• Last Update Posted: April 22, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual participant data will not be shared.

Additional relevant MeSH terms:

Barrett Esophagus; Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases