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

Launched by PENTAX MEDICAL · Jul 31, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called the CryoBalloon Focal Ablation System for people with Barrett Esophagus (BE), a condition where the cells in the esophagus change and can potentially lead to cancer. The goal is to see how effective and safe this treatment is for patients who have never been treated for BE before. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants must be at least 18 years old, have a specific type of Barrett Esophagus that has not been treated before (either low- or high-grade dysplastic BE), and have a certain length of BE. They should also be in good enough health to undergo the procedure and willing to follow up with the study requirements. Those participating can expect to receive the CryoBalloon treatment, which helps destroy the abnormal cells, and will be monitored closely for safety and effectiveness. It's important to note that individuals with certain conditions, such as esophageal cancer or severe health issues, may not qualify for this trial.

Gender

ALL

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