NCT03120195

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barretts Esophagus With Dysplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-27
• Primary completion: 2019-01-21
• Completion: 2019-06-18
• First posted: 2017-04-19
• Last updated: 2020-01-29

Locations

2 sites across 1 country: Netherlands