Navicam for Detection of Barrett's Esophagus
ConditionBarrett's Esophagus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMayo Clinic
About this trial
Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults greater than or equal to 22 years of age with or without 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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
NaviCam Detachable String Capsule
DeviceSubjects 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.
Treatment groups
57 Participants
are divided into 3 treatment groupsGroup A: Long Segment Barrett's Esophagus (LSBE)Experimental treatment 1 intervention
Group B: Short Segment Barrett's Esophagus (SSBE)Experimental treatment 1 intervention
Group C: Gastro Esophageal Reflux DiseaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of Columnar lined epithelium in the esophagus
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 outcomes
1
Visual Analogue Scale (VAS)
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.
Time frame
30 minutes post-procedure2
Spielberger State-Trait Anxiety Inventory (STAI-6)
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
Time frame
Baseline, 30 minutes post-procedure3
Impact of Events Scale (IES)
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.
Time frame
Baseline, 7 days post-procedureSponsors and contacts
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Source ClinicalTrials.gov