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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Foundation for Liver Research

Current Primary Outcome:

• Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis [ Time Frame: 3 months ]
  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 [ Time Frame: 3 months ]
  The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment

Original Primary Outcome: Same as current

Current Secondary Outcome:

• To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10) [ Time Frame: 1 month ]
  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) [ Time Frame: 1 month ]
  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) [ Time Frame: 1 month ]
  The symptoms will be recorded in a diary during the first 30 days post procedure
• Total time to resect tissue [ Time Frame: Procedure ]
  Procedure time is recorded during the EndoRotor® procedure
• Ease of performing the EndoRotor® procedure [ Time Frame: Procedure ]
  Procedural performance of the endoscopist will be assessed, using a predefined questionaire.

Original Secondary Outcome: Same as current

Information By: Foundation for Liver Research

Dates:
Date Received: April 4, 2017
Date Started: January 27, 2017
Date Completion: August 2017
Last Updated: April 18, 2017
Last Verified: April 2017