Endorotor Resection In Refractory Barrett's Dysplasia Patients

NCT03364114 | Terminated DMC FDA Device

• 1 other identifier: CLIN-0010
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 3

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.

Conditions

Barrett's Esophagus With Dysplasia

Outcome Measures

Primary Outcomes (2)

• Incidence of complete removal of refractory Barrett's esophagus

  The primary effectiveness endpoint for this study is the complete removal of refractory Barrett's esophagus in no more than three treatments as assessed by a biopsy negative for Barrett's esophagus at the 12 month follow-up visit.

  12 months

• Rate of device- and procedure-related serious adverse events (SAEs)

  The primary safety endpoint for this study is the rate of device- and procedure-related serious adverse events (SAEs) for bleeding, perforation, and stricture in the EndoRotor arm will be no greater than that of the continued ablative therapy arm.

  12 months

Secondary Outcomes (3)

• Activated Fibroblasts

  12 months

• Percent Reduction of Barrett's Esophagus

  12 months

• Post Procedure Pain

  9 months

Study Arms (2)

EndoRotor Resection

EXPERIMENTAL

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.

Device: EndoRotor Mucosal Resection System

Continued Ablation (Control)

ACTIVE COMPARATOR

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.

Device: Continued Ablation

Interventions

EndoRotor Mucosal Resection System DEVICE

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.

EndoRotor Resection

Continued Ablation DEVICE

Continued ablation control shall include either cryotherapy or continued radial frequency ablation.

Continued Ablation (Control)

Eligibility Criteria

• Age: 30 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Interscope, Inc.: lead

Study Sites (3)

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

NHS University College Hospital

London, United Kingdom

Location

Study Officials

• Kenneth Wang, MD

  The Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 6, 2017
• Study Start: February 9, 2018
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); US (1); GB (1)