EndoRotor Resection for Barrett's Esophagus

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byKenneth Wang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Interscope, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kenneth Wang, MD

Principal Investigator

The Mayo Clinic

Eligibility Criteria

This trial is for adults aged 30-90 with Barrett's esophagus and dysplasia who've had at least one failed ablation treatment and can't tolerate more due to pain, or have had three failed treatments. They must not have esophageal cancer, strictures blocking the endoscope, or be on certain blood thinners.

Inclusion Criteria

I have Barrett's esophagus with dysplasia, fit the study's health criteria, and can follow the study for 12 months.

I am between 30 and 90 years old.

Exclusion Criteria

My Barrett's esophagus is longer than 6 cm.

I have a blood clotting disorder.

I have nodular Barrett's esophagus.

See 14 more

Treatment Details

Interventions

Continued Ablation (Procedure)
EndoRotor Mucosal Resection System (Mucosal Resection System)

Trial OverviewThe study tests the EndoRotor® system in removing Barrett's esophagus tissue that hasn't responded to at least three prior ablations or when patients couldn't tolerate further ablation. It compares this method to continued standard ablation treatments.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: EndoRotor ResectionExperimental Treatment1 Intervention

For the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's.

Group II: Continued Ablation (Control)Active Control1 Intervention

The investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's.