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

Barrett Esophagus Clinical Trial

— ColdPlayIII  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02514525
• Other study ID #: CP-0011
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Pentax Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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.

Locations

Country	Name	City	State
United States	John Hopkins	Baltimore	Maryland
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Northwell Health	Manhasset	New York
United States	New York Presbyterian Hospital-Columbia University Medical Center	New York	New York
United States	UC Irvine	Orange	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Sarasota Memorial Hospital	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pentax Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious, CryoBalloon Ablation System-related adverse events		12 months
Primary	Percentage of patients with baseline LGD who have complete eradication of all dysplasia		12 months
Primary	percentage of patients with baseline HGD who have complete eradication of all dysplasia		12 months
Primary	percentage of all treated patients who have complete eradication of all dysplasia (CE-D)		12 months
Secondary	Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM)		12 months
Secondary	Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer	For Baseline LGD and HGD subjects: progression of dysplasia	12 months
Secondary	Incidence of all treatment-related and all serious, non-treatment-related adverse events		12 months
Secondary	Incidence of post procedure chest discomfort events / Pain score >0 and <5	(scored on a 0-10 visual analog pain scale)	Day 1
Secondary	Incidence of post procedure chest discomfort events / Pain score =5 and requiring narcotic analgesic	(scored on a 0-10 visual analog pain scale)	Day 7
Secondary	Mean and Median Pain score on Day 1 post procedure	(scored on a 0-10 visual analog pain scale)	Day 1
Secondary	Mean and Median Pain score on Day 7 post procedure	(scored on a 0-10 visual analog pain scale)	Day 7
Secondary	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		24 and 36 months
Secondary	Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM	(mean and median)	12 months