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

Pentax Medical

Status

Active, not recruiting

Conditions

Barrett Esophagus

Treatments

Device: CryoBalloon Ablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02514525

CP-0011

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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