Clinical trial NCT03364114: Endorotor Resection In Refractory Barrett's Dysplasia Patients
Official title: Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Barrett's Esophagus With Dysplasia
Lead sponsor: Interscope, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

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 ablative therapy in subjects with refractory Barrett's Esophagus.

The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females.
2. Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:

   1. Failed 3 ablative procedures (RFA and/or Cryotherapy).
   2. 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.
3. Residual Barrett's length is ≥1 cm and ≤6 cm.
4. No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.
5. Subject capable of giving informed consent.
6. Subject has a reasonable expectation for prolonged survival (greater than 2 years).
7. Subject can tolerate repeated endoscopic procedures.
8. Absence of strictures refractory to dilation that preclude the passage of the endoscope
9. 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.
10. 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:

1. Subject unable to give informed consent.
2. Subject is unwilling to return for repeated endoscopies.
3. Confirmed endoscopic and or histologic evidence of EAC at time of therapy.
4. Residual Barrett's longer than 6 cm.
5. Subjects with nodular Barrett's esophagus.
6. Subjects who are on anticoagulant therapy that cannot be discontinued for 5 days before and after the procedure.
7. Subjects with known coagulopathy defined as abnormal prothrombin or partial thromboplastin time.
8. History of esophageal varices
9. LA Grade B, C, or D esophagitis.
10. Esophageal stricture refractory to dilation preventing passage of endoscope or catheter.
11. Any previous esophageal surgery, except fundoplication without complications.
12. Medically uncorrectable hypotension or hypertension.
13. 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).
14. 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.
15. Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions.
16. Patient has a known significant concomitant illness with a life expectancy of less than 2 years.
17. Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Primary outcomes:
measure: Incidence of complete removal of refractory Barrett's esophagus
timeFrame: 12 months
measure: Rate of device- and procedure-related serious adverse events (SAEs)
timeFrame: 12 months
Secondary outcomes:
measure: Activated Fibroblasts
timeFrame: 12 months
measure: Percent Reduction of Barrett's Esophagus
timeFrame: 12 months
measure: Post Procedure Pain
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: London
country: United Kingdom
facility: NHS University College Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust and University of Nottingham
Study officials:
affiliation: The Mayo Clinic
name: Kenneth Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: