A Study to Evaluate the Endorotor® Resection In Refractory Barrett's Dysplasia Patients

Overview

About this study

The aim of the clinical trial is evaluate the EndoRotor®’s ability to completely remove areas of Barrett’s metaplasia considered refractory after failed ablative therapy.

 

 

 

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:

  • Subjects who are ≥ 30 and ≤ 90 years of age, inclusive of males and females.
  • Subjects with confirmed Barrett’s esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:
    • Failed 3 ablative procedures (RFA and/or Cryotherapy);
    • Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
  • Residual Barrett’s length is ≥ 1 cm and ≤ 6 cm.
  • No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.
  • Subject capable of giving informed consent.
  • Subject has a reasonable expectation for prolonged survival (greater than 2 years).
  • Subject can tolerate repeated endoscopic procedures.
  • Absence of strictures refractory to dilation that preclude the passage of the endoscope
  • Patients who were on acid suppression therapy (i.e., PPIs) during the course of failed primary ablative therapy, and who can continue acid suppression therapy for the entire time they are on the clinical study.
  • Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 12 months, as indicated.

Exclusion Criteria:

  • Subject unable to give informed consent.
  • Subject is unwilling to return for repeated endoscopies.
  • Confirmed endoscopic and / or histologic evidence of EAC at time of therapy
  • Residual Barrett’s longer than 6 cm.
  • Subjects with nodular Barrett’s Esophagus.
  • Subjects who are on anticoagulant therapy that cannot be discontinued for 5 days before and after the procedure.
  • Subjects with known coagulopathy defined as abnormal prothrombin or partial thromboplastin time.
  • Presence of esophageal varices.
  • LA Grade B, C, or D esophagitis.
  • Esophageal stricture refractory to dilation preventing passage of endoscope or catheter.
  • Any previous esophageal surgery, except fundoplication without complications.
  • Medically uncorrectable hypotension or hypertension.
  • Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
  • Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
  • Patient has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions.
  • Patient has a known significant concomitant illness with a life expectancy of < 2 years.
  • Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

 

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

Kenneth Wang, M.D.

Open for enrollment

Contact information:

Bryan Linn

(507)255-4631

Linn.Bryan@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-20399895

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