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Recruiting

NCT Number: NCT06748911

Navicam for Detection of Barrett's Esophagus

Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus

Recruiting

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Stephanie McNew, B.S.

CONTACT

[email protected]

904-953-0580

Swathi Eluri

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NaviCam Detachable String Capsule

Device

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 outcomes

  1. 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..

    Detection of Columnar lined epithelium in the esophagus

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Spielberger State-Trait Anxiety Inventory (STAI-6)

    Time frame: 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

  3. Impact of Events Scale (IES)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie McNew

CONTACT

[email protected]

904-953-5080

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus

Acronym: DS-MCE-BE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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