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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test NaviCam, a non-invasive capsule that enhances doctors' ability to detect Barrett's esophagus. Barrett's esophagus occurs when the esophagus lining changes, often due to acid reflux. The trial includes different groups: individuals with Long Segment Barrett's Esophagus (LSBE), Short Segment Barrett's Esophagus (SSBE), and those with Gastroesophageal Reflux Disease (GERD) who may require screening for Barrett's esophagus. This trial suits adults who have undergone an endoscopy in the past year and either have Barrett's esophagus or chronic GERD with specific risk factors. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future diagnostic methods.

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 prior data suggests that this capsule system is safe for detecting Barrett's esophagus?

Research has shown that NaviCam, a non-invasive capsule system, is used to detect Barrett's esophagus, a condition caused by long-term acid reflux. Although specific safety details for NaviCam aren't provided in the sources, its non-invasive nature suggests it might be well-tolerated. Non-invasive procedures do not involve any cuts, typically resulting in fewer risks and side effects compared to traditional surgeries or endoscopies.

The trial is marked as "Not Applicable" for phase, which may indicate that NaviCam is already in use or tested for similar conditions, suggesting some level of established safety. However, without specific study results, discussing potential risks and benefits with healthcare providers before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NaviCam for Barrett's Esophagus because it offers a new, non-invasive way to detect this condition. Unlike standard methods like endoscopy, which can be uncomfortable and require sedation, NaviCam uses a swallowable capsule equipped with a camera to scan the esophagus. This innovative approach makes screening more accessible and less daunting for patients, potentially catching the condition earlier. Additionally, NaviCam could improve patient compliance and streamline the diagnostic process, offering a more convenient alternative to traditional procedures.

What evidence suggests that the NaviCam system is effective for detecting Barrett's esophagus?

Research has shown that NaviCam, a swallowable capsule, could effectively detect Barrett's esophagus, a condition that can lead to cancer. In a small study involving 47 participants, NaviCam correctly identified 93.8% of those with the condition and accurately ruled out 100% of those without it. This indicates its high accuracy in detecting the condition and perfection in confirming its absence. As a non-invasive method, it offers a more comfortable alternative to traditional tests. Although further research is necessary to confirm these results, the initial findings are promising. Participants in this trial will be divided into groups based on their diagnosis, including Long Segment Barrett's Esophagus (LSBE), Short Segment Barrett's Esophagus (SSBE), and Gastroesophageal Reflux Disease (GERD) eligible for Barrett's Esophagus screening. ^{3 5 6 7 8}

Who Is on the Research Team?

Swathi Eluri

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inability to comprehend or read the consent form

Presence of pacemaker or implanted cardiac defibrillator

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

centerwatch.com

centerwatch.com/clinical-trials/listings/condition/766/barretts-esophagus

Barrett's Esophagus Clinical Research Trials

The annual rate of developing esophageal adenocarcinoma is around 0.2% to 0.5% in patients with BE. However, the annual adenocarcinoma progression risk is ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10922282/

Advances in Screening for Barrett's Esophagus and ...

Unfortunately, EAC still has a dismal 5-year survival rate of only 20%, partly due to the propensity for metastasis as the tumor is located in ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5198232/

Progression of Barrett's esophagus toward esophageal ...

In Barrett's esophagus, normal squamous epithelium is replaced by a metaplastic columnar epithelium as a consequence of chronic gastroesophageal reflux disease.

4.

researchgate.net

researchgate.net/publication/336945778_Diagnosis_of_Barrett's_esophagus_and_esophageal_varices_using_a_magnetically_assisted_capsule_endoscopy_system

Diagnosis of Barrett's esophagus and esophageal varices ...

A small proof-of-principal study of 47 patients (16 with BE) using MACE showed an increased sensitivity of 93.8% and specificity of 100%, and ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3767470/

Impact of Endoscopic Surveillance on Mortality From ...

Endoscopic surveillance of patients with Barrett's esophagus was not associated with a substantially decreased risk of death from esophageal adenocarcinoma.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06748911

Navicam for Detection of Barrett's Esophagus

Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest ...

7.

trialx.com

trialx.com/clinical-trials/listings/305888/navicam-for-detection-of-barretts-esophagus/

Navicam for Detection of Barrett's Esophagus

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

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06897540

NCT06897540 | Barrett's Esophagus in Patients with GERD

Also called a data safety and monitoring board ... Screening for Barrett's Esophagus in Patients with Gastroesophageal Reflux Disease: Hospital Based Study.