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

NCT02560623 | Completed Results FDA Device

• 3 other identifiers: 15-004540NCI-2022-08390P30CA015083
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 6

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.

Conditions

Barrett Esophagus

Keywords

Barrett's; esophagus; reflux; esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Number of Subjects That Would Have This Procedure Again

  Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"

  Within 24 hours of the capsule sponge administration

• Tolerability of Swallowing the Sponge Device

  Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure.

  Within 24 hours of the capsule sponge administration

• Mucosal Irritation

  Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted

  Within 24 hours of the capsule sponge administration

• DNA Yield

  Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.

  Within 24 hours of the capsule sponge administration

Secondary Outcomes (2)

• Sensitivity of Barrett's Dysplasia Detection

  Within 24 hours of the capsule sponge administration

• Specificity of Barrett's Dysplasia Detection

  Within 24 hours of the capsule sponge administration

Study Arms (4)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Phase 2: Cases - Barrett's Esophagus

EXPERIMENTAL

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

Procedure: Biopsy; Procedure: Endoscopic Procedure; Device: Swallowable Sponge Cell Sampling Device

Phase 2: Controls - No Barrett's Esophagus

EXPERIMENTAL

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

Procedure: Biopsy; Procedure: Endoscopic Procedure; Device: Swallowable Sponge Cell Sampling Device

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Phase 1: Sponge on a String 25 mm 10 pores/inch; Phase 1: Sponge on a String 25 mm 20 pores/inch; Phase 2: Cases - Barrett's Esophagus; Phase 2: Controls - No Barrett's Esophagus

Biospecimen Collection PROCEDURE

Undergo collection of blood sample

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Phase 1: Sponge on a String 25 mm 10 pores/inch; Phase 1: Sponge on a String 25 mm 20 pores/inch

Endoscopic Procedure PROCEDURE

Undergo endoscopy

Also known as: Endoscopic Examination, Endoscopy

Phase 1: Sponge on a String 25 mm 10 pores/inch; Phase 1: Sponge on a String 25 mm 20 pores/inch; Phase 2: Cases - Barrett's Esophagus; Phase 2: Controls - No Barrett's Esophagus

Swallowable Sponge Cell Sampling Device DEVICE

Undergo swallowable sponge cell sampling assessment

Also known as: Cytosponge, Swallowable Sponge, Swallowable Sponge Device

Phase 1: Sponge on a String 25 mm 10 pores/inch; Phase 1: Sponge on a String 25 mm 20 pores/inch; Phase 2: Cases - Barrett's Esophagus; Phase 2: Controls - No Barrett's Esophagus

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator
• Exact Sciences Corporation: collaborator

Study Sites (6)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Health System - Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (3)

• Iyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19.

  PMID: 38513982 DERIVED

• 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.

  PMID: 33857451 DERIVED

• 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.

  PMID: 29891853 DERIVED

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux; Adenocarcinoma Of Esophagus

Interventions

Biopsy; Specimen Handling; Endoscopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Prasad G. Iyer
• Organization: Mayo Clinic

iyer.Prasad@mayo.edu

507-293-7911

Study Officials

• Prasad G Iyer, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 25, 2015
• Study Start: October 15, 2015
• Primary Completion: June 29, 2021
• Study Completion: July 8, 2021
• Last Updated: November 17, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)