NaviCam for Barrett's Esophagus
(DS-MCE-BE Trial)
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.12345Why 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.35678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo a non-invasive capsule procedure for detection of Barrett's esophagus
Immediate Post-Procedure
Participants are assessed for anxiety and pain immediately after the procedure
Follow-up
Participants are monitored for distress and procedure acceptability
What Are the Treatments Tested in This Trial?
Interventions
- NaviCam
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor