EndoRotor Resection for Barrett's Esophagus

Recruiting at 4 trial locations

Overseen By Alexis James, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Interscope, Inc.

Must be taking: Acid suppression

Must not be taking: Anticoagulants

Disqualifiers: Esophageal cancer, Nodular Barrett's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 9 months

120 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EndoRotor resection or continued ablative therapy up to 3 times to remove Barrett's esophagus

9 months

Up to 3 treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and complete removal of Barrett's esophagus

12 months

Follow-up visits at 9 and 12 months

Treatment Details

Interventions

• Continued Ablation
• EndoRotor Mucosal Resection System

Trial Overview The 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

Group I: EndoRotor Resection Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Interscope, Inc.

Lead Sponsor

Trials

5

Recruited

310+