Using a capsule system to detect Barrett's Esophagus
Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus
This study is testing a new capsule system to see if it can help find Barrett's Esophagus in adults who have had an endoscopy recently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06748911 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the NaviCam Detachable String Capsule, a non-invasive capsule system designed to provide optimal viewing angles of the esophagus for the detection of Barrett's Esophagus. Participants will include adults who have undergone an endoscopy within the past year, with specific inclusion criteria for those with Barrett's Esophagus or chronic GERD. The study aims to improve the detection methods for this condition, potentially leading to better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who have had an endoscopy within the last year and meet specific criteria related to Barrett's Esophagus or chronic GERD.
Not a fit: Patients with active esophageal tumors, significant dysphagia, or those who have had certain types of esophageal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the early detection of Barrett's Esophagus, leading to timely interventions and improved patient management.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving detection methods for esophageal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Adults greater than or equal to 22 years of age with or without Barrett's Esophagus * All Patients: o Have had an endoscopy within 1 year of baseline enrollment * Patients with Barrett's Esophagus: * Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or * Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines Exclusion Criteria * Inability to comprehend or read the consent form * Have an oropharynx, esophageal, or gastro-esophageal tumor * Ongoing symptoms of dysphagia * Presence of active clinically significant stricture * History of stricture requiring dilation * Presence of pacemaker or implanted cardiac defibrillator * History of esophageal surgery with the exception of fundoplication * Pregnancy * History of surgery or obstructive process of the small bowel * BMI \> 38
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Swathi Eluri — Mayo Clinic
- Study coordinator: Stephanie McNew
- Email: McNew.Stephanie@mayo.edu
- Phone: 904-953-5080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.