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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
  • Endoscopically-visualized abnormalities such as masses or nodules within 4cm of the treatment zone. 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Prasad Iyer, M.D.

Closed for enrollment

Contact information:

Michele Johnson P.T.A., CCRP

(507) 255-8692

johnson.michele@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20266948

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