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Trial record 1 of 1 for:    03364114
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Endorotor Resection In Refractory Barrett's Dysplasia Patients

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ClinicalTrials.gov Identifier: NCT03364114
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Interscope, Inc.

Brief Summary:
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's metaplasia considered refractory after 3 failed radiofrequency ablations (RFA).

Condition or disease Intervention/treatment Phase
Barretts Esophagus With Dysplasia Device: EndoRotor Mucosal Resection System Device: Continued Ablation Not Applicable

Detailed Description:

This is a prospective, multi-center, randomized study to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory dysplastic Barrett's Esophagus. Subjects must have failed 3 RFA treatments (failure of Barrett's to respond to RFA with a decrease of at least 50% of its length) and following 3 RFA failures have no endoscopic and histologic evidence of esophageal adenocarcinoma at the time of therapy. The subjects are randomized and treated (up to 2 times) with either the EndoRotor® which resects the affected mucosa and submucosa (down to the muscularis propria layer), or with cryotherapy or ablative therapy of the persistent lesions. Subjects will be followed with biopsies of the resected areas at the time of surveillance endoscopies every 3 months until they have 2 consecutive negative endoscopies and biopsies (6 months).

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : October 11, 2019
Estimated Study Completion Date : October 11, 2019

Arm Intervention/treatment
Experimental: EndoRotor Resection
Intervention: A prospective, multi-center, randomized study to compare the safety and performance of the EndoRotor® Mucosal Resection System in 110 subjects with refractory dysplastic Barrett's Esophagus. The subjects are randomized and treated (up to 2 times) with either the EndoRotor® or control.
Device: 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.

Active Comparator: Continued Ablation (Control)
Intervention: A prospective, multi-center, randomized study to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in 110 subjects with refractory dysplastic Barrett's Esophagus. The subjects are randomized and treated (up to 2 times) with continued ablation using either cryotherapy or ablative therapy or the EndoRotor Resection Arm.
Device: Continued Ablation
Continued ablation control shall include either cryotherapy or continued radial frequency ablation.




Primary Outcome Measures :
  1. Complete removal of areas of Barrett's metaplasia after no more than two treatments [ Time Frame: 6 months ]
    The primary effectiveness endpoint will be measured by post-treatment visual appearance on surveillance endoscopies and the findings on histology from biopsies taken of the treatment site at each endoscopy.

  2. Assessment of Adverse Events (incidence, relationship to device and severity) compared to the control arm and the medical literature. [ Time Frame: 3 months ]
    Adverse events will be compared to the control therapy.


Secondary Outcome Measures :
  1. Percentage of Barrett's esophagus resected or ablated during the initial treatment session through the final follow-up visits. [ Time Frame: 6 months ]
    The secondary effectiveness endpoint will be measured by post-treatment visual appearance on surveillance endoscopies and the findings on histology from biopsies taken of the treatment site at each endoscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who are >30 and <79 years of age; inclusive of males and females.
  2. Subjects with a history of confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) refractory to radiofrequency ablation 3 times.
  3. Residual Barrett's length is ≥1 cm and ≤6 cm.
  4. Histologic persistence of intestinal metaplasia (any non-squamous epithelial lesion) following treatment and failed eradication.
  5. Following 3 failed RFA procedures with no confirmed evidence of EAC and having confirmed no endoscopic and histologic evidence of EAC at the time of therapy.
  6. Subject capable of giving informed consent.
  7. Subject has a reasonable expectation for prolonged survival (greater than 5 years).
  8. Subject can tolerate repeated endoscopic procedures.
  9. Absence of strictures that preclude the passage of the endoscope.
  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

Exclusion Criteria:

  1. Subject unable to give informed consent.
  2. Subject is unwilling to return for repeated endoscopies.
  3. Subject having 3 failed RFA procedures and confirmed endoscopic and 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 aspirin or anticoagulant therapy who cannot stop it and have had bleeding problems during previous endoscopic treatments.
  7. Esophageal varices.
  8. Active esophagitis.
  9. Esophageal stricture preventing passage of endoscope or catheter.
  10. Any previous esophageal surgery, except fundoplication without complications.
  11. Medically uncorrectable hypotension or hypertension.
  12. 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).
  13. 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.
  14. Patient has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions.
  15. Patient has a known significant concomitant illness with a life expectancy of <1 year.
  16. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364114


Contacts
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Contact: Eric Bannon, BA 781-710-8243 ebannon@alvamed.com
Contact: Jeffery B Ryan Jr, BA 617-360-1168 jeffery.ryan@interscopemed.com

Locations
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United States, Minnesota
The Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori Lutzke, BSN, RN    507-255-7495    lutzke.lori@mayo.edu   
Principal Investigator: Kenneth Wang, MD         
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Contact: Krystle Bittner, BSN, RN    585-737-5242    krystle_bittner@urmc.rochester.edu   
Principal Investigator: Vivek Kaul, MD         
United States, Pennsylvania
Hospital University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen DeMarshall, BSN, RN    215-349-8546    demarshm@pennmedicine.upenn.edu   
Principal Investigator: Gregory Ginsberg, MD         
Sub-Investigator: Gary Falk, MD         
United Kingdom
NHS University College Hospital Recruiting
London, United Kingdom
Contact: Mohamed HUSSEIN, MD    +44 7799 843218‬    mohamed.hussein3@nhs.net   
Contact: Christwishes Makahamadze    +447578254350    christwishes.makahamadze@nhs.net   
Principal Investigator: Rehan HaI, MD         
Sponsors and Collaborators
Interscope, Inc.
Investigators
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Principal Investigator: Kenneth Wang, MD The Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Interscope, Inc.:

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Responsible Party: Interscope, Inc.
ClinicalTrials.gov Identifier: NCT03364114     History of Changes
Other Study ID Numbers: CLIN-0010
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases