Back to resultsEndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
Primary Purpose
Barretts Esophagus With Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
The EndoRotor®
Sponsored by
About this trial
This is an interventional treatment trial for Barretts Esophagus With Dysplasia
Eligibility Criteria
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.
Sites / Locations
- Radboud University Medical Center
- Erasmus MC, University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EndoRotor® ablation
Arm Description
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®.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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
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
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
Total time to resect tissue
Procedure time is recorded during the EndoRotor® procedure
Ease of performing the EndoRotor® procedure
Procedural performance of the endoscopist will be assessed, using a predefined questionaire.
Full Information
NCT ID
NCT03120195
First Posted
April 4, 2017
Last Updated
January 28, 2020
Sponsor
Foundation for Liver Research
Collaborators
Interscope, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03120195
Brief Title
EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
Official Title
EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Liver Research
Collaborators
Interscope, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barretts Esophagus With Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EndoRotor® ablation
Arm Type
Experimental
Arm Description
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®.
Intervention Type
Device
Intervention Name(s)
The EndoRotor®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis
Description
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.
Time Frame
3 months
Title
Feasibility of EndoRotor® for the ablation of Barrett's mucosa
Description
The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)
Description
The discomfort score will be recorded in a diary during the first 30 days post procedure
Time Frame
1 month
Title
To assess the dysphagia-score (recorded using the Ogilvie score)
Description
The dysphasia score will be recorded in a diary during the first 30 days post procedure
Time Frame
1 month
Title
To assess a variety of symptoms (recorded using a 7 point Likert scale)
Description
The symptoms will be recorded in a diary during the first 30 days post procedure
Time Frame
1 month
Title
Total time to resect tissue
Description
Procedure time is recorded during the EndoRotor® procedure
Time Frame
Procedure
Title
Ease of performing the EndoRotor® procedure
Description
Procedural performance of the endoscopist will be assessed, using a predefined questionaire.
Time Frame
Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arjun D. Koch, MD, PhD
Organizational Affiliation
Erasmus MC, University Medical Center Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus MC, University Medical Center
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34521118
Citation
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;:
Results Reference
derived
Learn more about this trial
EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
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