NaviCam for Barrett's Esophagus

(DS-MCE-BE Trial)

Overseen By Stephanie McNew

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Tumors, Dysphagia, Pacemaker, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

57 Participants Needed

Trial Summary

Do I need to stop my current medications for the NaviCam trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus

Research Team

Swathi Eluri

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals who may have Barrett's Esophagus, a condition where the esophageal lining changes. Specific eligibility criteria are not provided, but typically participants should be adults with suspected or known Barrett's Esophagus and in stable health.

Inclusion Criteria

I have Barrett's Esophagus or severe acid reflux with additional risk factors.

I am 22 or older and had an endoscopy within the last year.

Exclusion Criteria

I have had surgery or a blockage in my small intestine.

Presence of pacemaker or implanted cardiac defibrillator

Inability to comprehend or read the consent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo a non-invasive capsule procedure for detection of Barrett's esophagus

30 minutes

1 visit (in-person)

Immediate Post-Procedure

Participants are assessed for anxiety and pain immediately after the procedure

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for distress and procedure acceptability

7 days

1 visit (virtual)

Treatment Details

Interventions

• NaviCam

Trial Overview The trial is testing the NaviCam Detachable String Capsule, a non-invasive device designed to provide detailed views of the esophagus to detect Barrett's Esophagus without requiring traditional endoscopy.

Participant Groups

Group I: Short Segment Barrett's Esophagus (SSBE) Experimental Treatment 1 Intervention

Subjects diagnosed with Short Segment Barrett's Esophagus (SSBE)

Group II: Long Segment Barrett's Esophagus (LSBE) Experimental Treatment 1 Intervention

Subjects diagnosed with Long Segment Barrett's Esophagus (LSBE)

Group III: Gastro Esophageal Reflux Disease Experimental Treatment 1 Intervention

Subjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+