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

Barretts Esophagus With Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120195
• Other study ID #: 2016-688
• Status: Completed
• Phase: N/A
• Start date: January 27, 2017
• Est. completion date: June 18, 2019

Study information

• Verified date: January 2020
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 18, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With Dysplasia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus MC, University Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Liver Research	Interscope, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Total time to resect tissue	Procedure time is recorded during the EndoRotor® procedure	Procedure
Secondary	Ease of performing the EndoRotor® procedure	Procedural performance of the endoscopist will be assessed, using a predefined questionaire.	Procedure