EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study

The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.

Study Overview

• Status: Completed
• Conditions: Barretts Esophagus With Dysplasia
• Intervention / Treatment: Device: The EndoRotor®

Detailed Description

Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. These include patients with low grade dysplasia (LGD), high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered.

The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center
  • Rotterdam, Netherlands
    • Erasmus MC, University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Age equal to or above 18 years (adult).
• Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)

• Scheduled Barrett's ablation for:

  • Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
  • Residual Barrett's mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR <50% of the circumference)
• Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.

Exclusion Criteria:

• Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
• In case of previous EMR: EMR specimen showing deep submucosal invasion (> 500μm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
• In case of previous EMR: > 50% circumference.
• Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
• Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
• Evidence of portal hypertension, esophageal varices, etc.
• An interval < 6 weeks between EMR and EndoRotor treatment.
• An interval of > 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
• Unable to undergo endoscopic procedure using sedation analgesics.
• Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EndoRotor® ablation; Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. Barrett's ablation will be performed using the EndoRotor®.	Device: The EndoRotor®; The EndoRotor® is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis	Participants will have follow-up visits after the procedure during which the occurence of adverse events will be assessed. Adverse events will be classified according to the severity and onset timing.	3 months
Feasibility of EndoRotor® for the ablation of Barrett's mucosa	The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)	The discomfort score will be recorded in a diary during the first 30 days post procedure	1 month
To assess the dysphagia-score (recorded using the Ogilvie score)	The dysphasia score will be recorded in a diary during the first 30 days post procedure	1 month
To assess a variety of symptoms (recorded using a 7 point Likert scale)	The symptoms will be recorded in a diary during the first 30 days post procedure	1 month
Total time to resect tissue	Procedure time is recorded during the EndoRotor® procedure	Procedure
Ease of performing the EndoRotor® procedure	Procedural performance of the endoscopist will be assessed, using a predefined questionaire.	Procedure

Collaborators and Investigators

• Sponsor: Foundation for Liver Research
• Collaborators: Interscope, Inc.
• Investigators: Principal Investigator: Arjun D. Koch, MD, PhD, Erasmus MC, University Medical Center Rotterdam

Publications and helpful links

General Publications

• Gotink AW, Peters Y, Bruno MJ, Siersema PD, Koch AD. Nonthermal resection device for ablation of Barrett's esophagus: a feasibility and safety study. Endoscopy. 2022 Jun;54(6):545-552. doi: 10.1055/a-1644-4326. Epub 2021 Dec 21. Erratum In: Endoscopy. 2022 Mar 09;:

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): January 21, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 2016-688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No