Barrett's Esophagus
Conditions
Brief summary
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
Interventions
DEVICENaviCam 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.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Columnar lined epithelium in the esophagus | From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure.. | Detection of Columnar lined epithelium in the esophagus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 30 minutes post-procedure | Visual Analogue Scale (VAS) is an 11-tem questionnaire assessing pain, where 0 represents the "worst experience" and 10 the "best experience". Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. |
| Spielberger State-Trait Anxiety Inventory (STAI-6) | Baseline, 30 minutes post-procedure | Patient anxiety will be measured using the shorter 6 item form of the Spielberger State-Trait Anxiety Inventory (STAI-6), with a score over 40 as a threshold for clinically significant anxiety |
| Impact of Events Scale (IES) | Baseline, 7 days post-procedure | The Impact of Events Scale (IES) will be used to assess distress associated with the procedure and procedure acceptability. The IES is rated on a scale of 0 (not at all) to 4 (extremely), with higher scores indicating a greater level of distress. |
Countries
United States
Contacts
CONTACTStephanie McNew
PRINCIPAL_INVESTIGATORSwathi Eluri
Mayo Clinic
Outcome results
None listed