EndoRotor Resection for Barrett's Esophagus

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for Barrett's esophagus, a condition where the esophageal lining changes and may lead to cancer. The trial compares the EndoRotor Mucosal Resection System, which removes damaged tissue, with standard treatments like radiofrequency ablation or cryotherapy. Suitable participants have had Barrett's esophagus for a while, tried other treatments without success, or cannot tolerate the pain from previous treatments. The goal is to determine if the EndoRotor more effectively removes damaged tissue for those who haven't found relief with other methods. As an unphased trial, this study offers patients the chance to explore a potentially more effective treatment option for Barrett's esophagus.

Do I have to stop taking my current medications for the trial?

The trial requires that you continue taking acid suppression therapy (like PPIs) if you were on it during previous treatments. If you're on anticoagulant therapy, you must stop it for 5 days before and after the procedure.

What prior data suggests that the EndoRotor Mucosal Resection System is safe for treating Barrett's esophagus?

Research has shown that the EndoRotor Mucosal Resection System holds promise for safely treating Barrett's esophagus. In previous studies, it successfully worked in 97.6% of cases. Importantly, it did not cause esophageal narrowing, and patients reported low pain levels. Some side effects, such as small tears and bleeding, occurred but were monitored for three months. Overall, the EndoRotor appears well-tolerated, with many patients not experiencing serious side effects. However, larger studies are needed to better understand any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EndoRotor Mucosal Resection System for Barrett's Esophagus because it offers a new approach to removing abnormal esophageal tissue. Unlike standard treatments like radiofrequency ablation (RFA) or cryotherapy, which work by destroying tissue with heat or cold, the EndoRotor physically resects and removes the tissue. This system uses a specialized device during an endoscopic procedure, aiming to provide a more precise and potentially more effective treatment. By directly removing the tissue, it may reduce the risk of incomplete eradication and recurrence, offering hope for improved outcomes in patients with Barrett's Esophagus.

What evidence suggests that the EndoRotor Mucosal Resection System is effective for Barrett's esophagus?

Research has shown that the EndoRotor Mucosal Resection System, which participants in this trial may receive, effectively treats challenging cases of Barrett's Esophagus. One study demonstrated that the device successfully removed difficult lesions in 71.4% of patients who had not improved with other treatments. This suggests that EndoRotor could be a viable option for patients who cannot tolerate or have not benefited from traditional heat-based therapies. It is also considered a safe and effective method for removing Barrett's tissue without using heat. These findings strongly indicate that it can assist patients when other treatments have failed. ^{1 3 4 6 7}

Who Is on the Research Team?

Kenneth Wang, MD

Principal Investigator

The Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04867590

A Study Comparing the Effectiveness of EndoRotor Versus ... A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus (ENDOBARRETT). ClinicalTrials.gov ID NCT04867590.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32621818/

Safety and efficacy of a novel powered endoscopic ... The EndoRotor is a novel, effective, and safe PED device for endoscopic resection of flat and polypoid lesions in the colon and foregut.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6068777/

Non-thermal ablation of non-neoplastic Barrett's ... EndoRotor® resection is a feasible non-thermal treatment of non-neoplastic Barrett's esophagus. Larger trials have to evaluate risks and ...

4. journals.lww.com journals.lww.com/ajg/abstract/2019/10001/866_safety_and_efficacy_of_the_novel_endorotor_.866.aspx

866 Safety and Efficacy of the Novel Endorotor® Mucosal... Most (n = 25; 71.4%) patients had a prior resection attempt for the same indication using standard techniques; ER-EMR was successful in all these difficult ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468900925000672

Endoscopic submucosal dissection versus ... ESD significantly outperformed EMR in en bloc resection (RR = 2.22, 95% CI: 1.69–2.90; p < 0.001), R0 resection (RR = 1.93, 95% CI: 1.28–2.91; p ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03120195

EndoRotor® Ablation of Barrett's Esophagus: Safety and ... During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered. The EndoRotor® System ...

7. giejournal.org giejournal.org/article/S0016-5107(20)32714-0/fulltext

REPORT OF INITIAL OUTCOMES EndoRotor is safe to use in the treatment of refractory BE with no associated strictures and low pain scores.