Clinical trial NCT02514525: Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2015-08-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Eligibility 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

Primary outcomes:
measure: Incidence of serious, CryoBalloon Ablation System-related adverse events
timeFrame: 12 months
measure: Percentage of patients with baseline LGD who have complete eradication of all dysplasia
timeFrame: 12 months
measure: percentage of patients with baseline HGD who have complete eradication of all dysplasia
timeFrame: 12 months
measure: percentage of all treated patients who have complete eradication of all dysplasia (CE-D)
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM)
timeFrame: 12 months
measure: Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer
timeFrame: 12 months
measure: Incidence of all treatment-related and all serious, non-treatment-related adverse events
timeFrame: 12 months
measure: Incidence of post procedure chest discomfort events / Pain score >0 and <5
timeFrame: Day 1
measure: Incidence of post procedure chest discomfort events / Pain score ≥5 and requiring narcotic analgesic
timeFrame: Day 7
measure: Mean and Median Pain score on Day 1 post procedure
timeFrame: Day 1
measure: Mean and Median Pain score on Day 7 post procedure
timeFrame: Day 7
measure: 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
timeFrame: 24 and 36 months
measure: Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine
state: California
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Medical Center
name: Marcia Canto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.