Status:
UNKNOWN
Endorotor Resection In Refractory Barrett's Dysplasia Patients
Lead Sponsor:
Interscope, Inc.
Conditions:
Barrett's Esophagus With Dysplasia
Eligibility:
All Genders
30-89 years
Phase:
NA
Brief Summary
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablatio...
Detailed Description
Prospective, multi-center, randomized controlled trial, pivotal, investigational device exemption (IDE) to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ...
Eligibility Criteria
Inclusion
- Subjects who are greater than 30 and less than 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
- 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.
- History 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.
- Subject 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 less than 2 years.
- Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03364114
Start Date
February 9 2018
End Date
December 31 2024
Last Update
August 3 2022
Active Locations (5)
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1
The Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Rochester Medical Center
Rochester, New York, United States, 14642
3
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
4
NHS University College Hospital
London, United Kingdom