Clinical trial NCT02560623: A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
Official title: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Keywords: Barrett's
esophagus
reflux
esophageal adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Exact Sciences Corporation
First posted: 2015-09-25
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.

Detailed description: This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.

Eligibility criteria: Inclusion Criteria:

Subjects with known Barrett's Esophagus (BE).

* Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
* Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
* Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy

Exclusion Criteria:

* Subjects with known BE.

  * Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
  * Patients with history of esophageal resection for esophageal carcinoma. Subjects with or without known evidence of BE (on history or review of medical records).
  * Pregnant or lactating females.
  * Patients who are unable to consent.
  * Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
  * Patients on oral anticoagulation including Coumadin, Warfarin.
  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
  * Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
  * Patients with history of known varices or cirrhosis.
  * Patients with history of esophageal resection for esophageal carcinoma.
  * Patients with congenital or acquired bleeding diatheses.
  * Patients with a history of esophageal squamous dysplasia.
  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

Primary outcomes:
measure: Number of Subjects That Would Have This Procedure Again
timeFrame: Within 24 hours of the capsule sponge administration
measure: Tolerability of Swallowing the Sponge Device
timeFrame: Within 24 hours of the capsule sponge administration
measure: Mucosal Irritation
timeFrame: Within 24 hours of the capsule sponge administration
measure: DNA Yield
timeFrame: Within 24 hours of the capsule sponge administration
Secondary outcomes:
measure: Sensitivity of Barrett's Dysplasia Detection
timeFrame: Within 24 hours of the capsule sponge administration
measure: Specificity of Barrett's Dysplasia Detection
timeFrame: Within 24 hours of the capsule sponge administration
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Mankato
country: United States
facility: Mayo Clinic Health System - Mankato
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Mayo Clinic in Rochester
name: Prasad G Iyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iyer PG, Taylor WR, Slettedahl SW, Lansing RL, Hemminger LL, Cayer FK, Mahoney DW, Giakoumopoulos M, Allawi HT, Wu TT, Wang KK, Wolfsen HC, Antpack E, Kisiel JB. Validation of a methylated DNA marker panel for the nonendoscopic detection of Barrett's esophagus in a multisite case-control study. Gastrointest Endosc. 2021 Sep;94(3):498-505. doi: 10.1016/j.gie.2021.03.937. Epub 2021 Apr 20.
citation: Iyer PG, Taylor WR, Johnson ML, Lansing RL, Maixner KA, Yab TC, Simonson JA, Devens ME, Slettedahl SW, Mahoney DW, Berger CK, Foote PH, Smyrk TC, Wang KK, Wolfsen HC, Ahlquist DA. Highly Discriminant Methylated DNA Markers for the Non-endoscopic Detection of Barrett's Esophagus. Am J Gastroenterol. 2018 Aug;113(8):1156-1166. doi: 10.1038/s41395-018-0107-7. Epub 2018 Jun 12.