Clinical Trial: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
Brief Summary: This study will evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus
Detailed Summary: Assess the sensitivity and specificity of a panel of DNA methylation markers in the non-endoscopic detection of Barrett's Esophagus as well as dysplasia/carcinoma using a capsule sponge device.
Sponsor: Mayo Clinic
Current Primary Outcome: Sensitivity and specificity of Barrett's Esophagus Diagnosis [ Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months. ]
Original Primary Outcome: Proportion of subjects able to swallow and extract sponge successfully (in all four sponge groups) [ Time Frame: Immediate ]
Current Secondary Outcome: Sensitivity and specificity of Barrett's dysplasia detection [ Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months. ]
Original Secondary Outcome:
- Mean endoscopic injury score in each of four sponge groups. [ Time Frame: 24 hours ]Presence and degree of mucosal abrasions scored from 1-6 (1=no evidence of trauma; 6= bleeding requiring endoscopic therapy) on endoscopic evaluation following sponge.
- Mean DNA yield (measured in nanograms) from sponges in each of four categories. [ Time Frame: 30 days ]DNA will be extracted from sponges in the laboratory using standard methods
Information By: Mayo Clinic
Dates:
Date Received: September 21, 2015
Date Started: October 2015
Date Completion: June 2019
Last Updated: February 8, 2017
Last Verified: February 2017