A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

Mayo Clinic

Status: Completed

Conditions: Barrett Esophagus

Treatments: Device: Swallowable Sponge Cell Sampling Device; Procedure: Endoscopic Procedure; Procedure: Biopsy; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02560623

P30CA015083 (U.S. NIH Grant/Contract)

15-004540

NCI-2022-08390 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 4 patient groups

Phase 1: Sponge on a String 25 mm 10 pores/inch

Experimental group

Description:

In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy

Treatment:

Procedure: Biospecimen Collection

Procedure: Endoscopic Procedure

Procedure: Biopsy

Device: Swallowable Sponge Cell Sampling Device

Phase 1: Sponge on a String 25 mm 20 pores/inch

Experimental group

Description:

In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy

Treatment:

Procedure: Biospecimen Collection

Procedure: Endoscopic Procedure

Procedure: Biopsy

Device: Swallowable Sponge Cell Sampling Device

Phase 2: Cases - Barrett's Esophagus

Experimental group

Description:

In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy

Treatment:

Procedure: Endoscopic Procedure

Procedure: Biopsy

Device: Swallowable Sponge Cell Sampling Device

Phase 2: Controls - No Barrett's Esophagus

Experimental group

Description:

In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy

Treatment:

Procedure: Endoscopic Procedure

Procedure: Biopsy

Device: Swallowable Sponge Cell Sampling Device