Clinical Trial Using the C2 Cryoballoon™ - for the Treatment of Non-Dysplastic, Low Grade Dysplastic or Indefinite for Dysplasia Barrett’s Esophagus

Overview

About this study

The primary objective is to determine the safety of the C2 CryoBalloon Full Ablation System (“CryoBalloon Full”) used at increasing doses in subjects with non-dysplastic, Low-Grade Dysplastic (LGD) or indefinite for dysplasia Barrett’s Epithelium (BE).              

A secondary objective is to evaluate CryoBalloon Full efficacy, evaluated by the percentage of regression of BE after ablation at a particular dose with the Full Ablation System.

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

  1. Diagnosis of non-dysplastic, LGD, or indefinite for dysplasia BE (confirmed by baseline histopathological analysis) that is non-nodular and previously untreated (“treatment naïve”).  Endoscopic mucosal resection (EMR) may be done to treat visible BE ≥6 weeks prior to enrolling the patient to this study.
  2. BE lesion length ≤3cm
  3. Prague Classification Score C>2 / M>2
  4. Older than 18 years of age at time of consent
  5. Operable per institution’s standards
  6. Provides written informed consent on the IRB/EC-approved informed consent form
  7. Willing and able to comply with follow-up requirements

Exclusion Criteria

  1. High-grade dysplastic (HGD) Barrett’s Epithelium, or intramucosal cancer (ImCA)
  2. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.  Patient may have the stenosis or stricture dilated and then be treated with the CryoBalloon Full under this protocol at a subsequent procedure ≥2 weeks later.
  3. Symptomatic untreated stricture
  4. Any endoscopically visualized lesion such as ulcers, masses or nodules.  Neoplastic nodules must first be treated with EMR >6 weeks prior to planned treatment under this protocol.
  5. Prior EMR >2cm in length and >50% of the esophageal lumen circumference
  6. History of esophageal cancer
  7. History of esophageal varices
  8. Prior distal esophagectomy
  9. Active esophagitis LA grade B or higher (patient may have esophagitis treated and then have CryoBalloon Full ablation under this protocol at a subsequent procedure >2 weeks later)
  10. Severe medical comorbidities precluding endoscopy
  11. Uncontrolled coagulopathy
  12. Pregnant or planning to become pregnant during period of study
  13. Patient refuses or is unable to provide written informed consent
  14. Life expectancy ≤2 years, as judged by the site investigator
  15.  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

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Closed for enrollment

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-20303064

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