NCT03364114

Endorotor Resection In Refractory Barrett's Dysplasia Patients

Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Interscope, Inc. · Industry
• Sex: All
• Age: 30 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

Detailed description

Prospective, multi-center, randomized controlled trial, pivotal, investigational device exemption (IDE) to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory Barrett's Esophagus. The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.

Conditions

• Barrett's Esophagus With Dysplasia

Interventions

Type	Name	Description
DEVICE	EndoRotor Mucosal Resection System	The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
DEVICE	Continued Ablation	Continued ablation control shall include either cryotherapy or continued radial frequency ablation.

Timeline

• Start date: 2018-02-09
• Primary completion: 2026-03-24
• Completion: 2026-03-24
• First posted: 2017-12-06
• Last updated: 2026-03-27

Locations

3 sites across 3 countries: United States, Sweden, United Kingdom

Regulatory

• FDA-regulated device study