Actively Recruiting
Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus
Led by Mayo Clinic · Updated on 2026-04-03
57
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a non-invasive method using the NaviCam Detachable String Capsule to improve viewing of the esophagus for detecting Barrett's Esophagus. This study involves adults aged 22 and older, including those diagnosed with Long Segment Barrett's Esophagus, Short Segment Barrett's Esophagus, and patients with Gastro Esophageal Reflux Disease (GERD) eligible for Barrett's screening. The goal is to enhance detection accuracy by assessing the esophageal lining. Participants will swallow the NaviCam capsule with water while sitting upright. The capsule will travel to the stomach's entry point, then be slowly pulled back using a string to inspect different sections of the esophagus under real-time video guidance. Images will be captured at two frames per second to help identify abnormal tissue. The study includes different groups based on Barrett's Esophagus type or GERD diagnosis. Throughout the procedure, researchers will monitor the detection of columnar lined epithelium in the esophagus within 30 minutes. Participants will also complete assessments measuring anxiety and discomfort shortly after the procedure and up to seven days later. The study will last from the initial procedure through follow-up assessments, ensuring safety and gathering detailed information about the capsule's effectiveness for esophageal evaluation.
CONDITIONS
Brief Title
Navicam for Detection of Barrett's Esophagus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults greater than or equal to 22 years of age with or without Barrett's Esophagus
- Have had an endoscopy within 1 year of baseline enrollment
- Patients with Barrett's Esophagus who have at least 1 cm of salmon colored mucosa with biopsies showing intestinal metaplasia, treatment naive and undergoing surveillance
- Chronic GERD patients with at least 3 additional risk factors meeting Barrett's Esophagus screening criteria per latest guidelines
You will not qualify if you...
- Unable to comprehend or read the consent form
- Presence of an oropharynx, esophageal, or gastro-esophageal tumor
- Ongoing symptoms of dysphagia
- Active clinically significant esophageal stricture
- History of stricture requiring dilation
- Presence of pacemaker or implanted cardiac defibrillator
- History of esophageal surgery except fundoplication
- Pregnancy
- History of surgery or obstruction of the small bowel
- Body mass index greater than 38
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 30 minutes
Participants swallow the NaviCam detachable string capsule to inspect the esophagus and detect Barrett's Esophagus through real-time imaging.
1 procedure visit (in-person)
Duration - 7 days
Participants complete assessments including anxiety and impact of events questionnaires at baseline, 30 minutes, and 7 days post-procedure.
1 baseline visit, 1 post-procedure visit at 30 minutes, and 1 follow-up visit at 7 days
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
S
Stephanie McNew
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
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