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Mucosal Resection System

EndoRotor Resection for Barrett's Esophagus

N/A

Recruiting

Led By Kenneth Wang, MD

Research Sponsored by Interscope, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Residual Barrett's longer than 6 cm

Subjects with known coagulopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device to treat Barrett's esophagus, a condition where the lining of the esophagus changes. The device is being tested to see if it can remove areas of Barrett's esophagus that haven't responded to other treatments, or if it can be used on patients who can't tolerate other treatments due to pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from repeated endoscopic procedures, risks associated with sedation, bleeding, infection risk post-procedure, and possible short-term swallowing difficulties.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My Barrett's esophagus is longer than 6 cm.

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I have a blood clotting disorder.

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I have nodular Barrett's esophagus.

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I am not willing to undergo multiple endoscopies.

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My esophageal cancer has been confirmed by a scope or biopsy.

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I have had swollen veins in my esophagus.

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My esophagitis is moderate to severe.

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I have had esophageal surgery, but not fundoplication or it was without complications.

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My blood pressure cannot be controlled with medication.

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I have a serious illness and am expected to live less than 2 years.

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I am unable to understand and give consent for my treatment.

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I have a narrow esophagus that can't be widened, blocking medical instruments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of complete removal of refractory Barrett's esophagus

Rate of device- and procedure-related serious adverse events (SAEs)

Secondary study objectives

Activated Fibroblasts

Percent Reduction of Barrett's Esophagus

Post Procedure Pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 12Eligibility criteria met