Recruiting NCT06748911
Navicam for Detection of Barrett's Esophagus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NaviCam Detachable String Capsule.
- Who it may be relevant to
- Registry conditions: Barrett's Esophagus. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of a Detachable String Capsule for Evaluation 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
Interventions
- Device NaviCam Detachable String Capsule
Subjects will swallow the NaviCam capsule with 20 ml water while positioned in the upright position. Once the capsule reaches the gastric cardia, the string will slowly be pulled up to systematically inspect the Z-line and upper, middle, and lower thirds of the esophagus guided by real-time viewing and by moving the capsule solely with the tether. Images will be captured at a rate of 2 frames per second.
Primary outcome measures
- Detection of Columnar lined epithelium in the esophagus [Time frame: From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure..]
Secondary outcome measures (3)
- Visual Analogue Scale (VAS) [Time frame: 30 minutes post-procedure]
- Spielberger State-Trait Anxiety Inventory (STAI-6) [Time frame: Baseline, 30 minutes post-procedure]
- Impact of Events Scale (IES) [Time frame: Baseline, 7 days post-procedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT06748911 · 24-000150