Endorotor Resection In Refractory Barrett's Dysplasia Patients
NCT ID: NCT03364114
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-02-09
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EndoRotor Resection
For the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's.
EndoRotor Mucosal Resection System
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.
Continued Ablation (Control)
The investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's.
Continued Ablation
Continued ablation control shall include either cryotherapy or continued radial frequency ablation.
Interventions
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EndoRotor Mucosal Resection System
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.
Continued Ablation
Continued ablation control shall include either cryotherapy or continued radial frequency ablation.
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
89 Years
ALL
No
Sponsors
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Interscope, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Wang, MD
Role: PRINCIPAL_INVESTIGATOR
The Mayo Clinic
Locations
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The Mayo Clinic
Rochester, Minnesota, United States
University of Rochester Medical Center
Rochester, New York, United States
Sahlgrenska University Hospital
Gothenburg, , Sweden
NHS University College Hospital
London, , United Kingdom
Nottingham University Hospitals NHS Trust and University of Nottingham
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLIN-0010
Identifier Type: -
Identifier Source: org_study_id
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