Pilot Study of Esocheck in Eosinophilic Esophagitis

NCT04311970 | Completed FDA Device

• 1 other identifier: 833846
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Eosinophilic esophagitis (EoE) is a prevalent chronic inflammatory condition of the esophagus characterized by esophageal eosinophilia that can lead to inflammation and stricture formation. To assess remission, esophagogastroduodenoscopies (EGD) with biopsies are performed. This can lead to multiple EGDs, which are invasive and costly procedures. EsoCheck is a promising noninvasive device. It is an encapsulated balloon that can be easily swallowed and collect cells from the distal esophagus. The primary aim of this study is to determine the feasibility and safety of EsoCheck compared with standard endoscopy and biopsies in the assessment of EoE. This will be a prospective cross-sectional study of adult patients (greater than or equal to 22 years of age) at the University of Pennsylvania with a diagnosis of EoE scheduled for a clinically indicated upper endoscopy.

Conditions

Eosinophilic Esophagitis; Diagnoses Disease

Keywords

eosinophilic esophagitis

Outcome Measures

Primary Outcomes (2)

• Safety - Incidence of Adverse Events

  One of the primary endpoints will be incidence of adverse events.This will be determined by chart review, telephone call, and any adverse events listed by endoscopist during procedure.

  12 months

• Feasibility - Incidence of patient being able to complete intervention of EsoCheck

  The incidence that patient is able to complete EsoCheck. This will be determined by a yes/no survey by the endoscopist stating whether or not the patient successfully completed the intervention.

  12 months

Secondary Outcomes (2)

• Sensitivity and Specificity of EsoCheck

  12 months

• Sensitivity and Specificity of Brush Cytology

  12 months

Study Arms (1)

EoE patients

OTHER

Patients will all be administered the EsoCheck device as a diagnostic test

Device: EsoCheck

Interventions

EsoCheck DEVICE

All patients with known diagnosis of EoE will be administered the EsoCheck device prior to standard of care endoscopy

EoE patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 22 years of age
• Known EoE
• Previously scheduled upper endoscopy at the University of Pennsylvania

You may not qualify if:

• do not want to participate
• known or suspected contraindication for esophageal intubation
• esophageal stricture with inability to pass an endoscope
• history of esophageal perforation
• history of esophageal resection
• esophageal diverticula
• esophageal fistula
• pill dysphagia
• pill swallowing phobia
• food impaction
• esophageal varices
• coagulopathy
• active anticoagulation or antithrombotic
• active GI bleeding
• pregnancy.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Lucid Diagnostics, Inc.: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (13)

• Lucendo AJ, Molina-Infante J, Arias A, von Arnim U, Bredenoord AJ, Bussmann C, Amil Dias J, Bove M, Gonzalez-Cervera J, Larsson H, Miehlke S, Papadopoulou A, Rodriguez-Sanchez J, Ravelli A, Ronkainen J, Santander C, Schoepfer AM, Storr MA, Terreehorst I, Straumann A, Attwood SE. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017 Apr;5(3):335-358. doi: 10.1177/2050640616689525. Epub 2017 Jan 23.

  PMID: 28507746 BACKGROUND

• Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.

  PMID: 23567357 BACKGROUND

• Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.

  PMID: 21477849 BACKGROUND

• Hiremath G, Gupta SK. Promising Modalities to Identify and Monitor Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1655-1664. doi: 10.1016/j.cgh.2017.05.004. Epub 2017 May 10.

  PMID: 28501533 BACKGROUND

• Katzka DA, Geno DM, Ravi A, Smyrk TC, Lao-Sirieix P, Miremadi A, Debiram I, O'Donovan M, Kita H, Kephart GM, Kryzer LA, Camilleri M, Alexander JA, Fitzgerald RC. Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2015 Jan;13(1):77-83.e2. doi: 10.1016/j.cgh.2014.06.026. Epub 2014 Jul 3.

  PMID: 24997328 BACKGROUND

• Katzka DA, Smyrk TC, Alexander JA, Geno DM, Beitia RA, Chang AO, Shaheen NJ, Fitzgerald RC, Dellon ES. Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study. Am J Gastroenterol. 2017 Oct;112(10):1538-1544. doi: 10.1038/ajg.2017.244. Epub 2017 Aug 15.

  PMID: 28809387 BACKGROUND

• Furuta GT, Kagalwalla AF, Lee JJ, Alumkal P, Maybruck BT, Fillon S, Masterson JC, Ochkur S, Protheroe C, Moore W, Pan Z, Amsden K, Robinson Z, Capocelli K, Mukkada V, Atkins D, Fleischer D, Hosford L, Kwatia MA, Schroeder S, Kelly C, Lovell M, Melin-Aldana H, Ackerman SJ. The oesophageal string test: a novel, minimally invasive method measures mucosal inflammation in eosinophilic oesophagitis. Gut. 2013 Oct;62(10):1395-405. doi: 10.1136/gutjnl-2012-303171. Epub 2012 Aug 15.

  PMID: 22895393 BACKGROUND

• Moinova HR, LaFramboise T, Lutterbaugh JD, Chandar AK, Dumot J, Faulx A, Brock W, De la Cruz Cabrera O, Guda K, Barnholtz-Sloan JS, Iyer PG, Canto MI, Wang JS, Shaheen NJ, Thota PN, Willis JE, Chak A, Markowitz SD. Identifying DNA methylation biomarkers for non-endoscopic detection of Barrett's esophagus. Sci Transl Med. 2018 Jan 17;10(424):eaao5848. doi: 10.1126/scitranslmed.aao5848.

  PMID: 29343623 BACKGROUND

• Reed CC, Dellon ES. Eosinophilic Esophagitis. Med Clin North Am. 2019 Jan;103(1):29-42. doi: 10.1016/j.mcna.2018.08.009. Epub 2018 Nov 1.

  PMID: 30466674 BACKGROUND

• Alexander JA, Jung KW, Arora AS, Enders F, Katzka DA, Kephardt GM, Kita H, Kryzer LA, Romero Y, Smyrk TC, Talley NJ. Swallowed fluticasone improves histologic but not symptomatic response of adults with eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):742-749.e1. doi: 10.1016/j.cgh.2012.03.018. Epub 2012 Apr 1.

  PMID: 22475741 BACKGROUND

• Jensen ET, Kappelman MD, Martin CF, Dellon ES. Health-care utilization, costs, and the burden of disease related to eosinophilic esophagitis in the United States. Am J Gastroenterol. 2015 May;110(5):626-32. doi: 10.1038/ajg.2014.316. Epub 2014 Sep 30.

  PMID: 25267327 BACKGROUND

• Kim HP, Vance RB, Shaheen NJ, Dellon ES. The prevalence and diagnostic utility of endoscopic features of eosinophilic esophagitis: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Sep;10(9):988-96.e5. doi: 10.1016/j.cgh.2012.04.019. Epub 2012 May 18.

  PMID: 22610003 BACKGROUND

• van Rhijn BD, Verheij J, Smout AJ, Bredenoord AJ. The Endoscopic Reference Score shows modest accuracy to predict histologic remission in adult patients with eosinophilic esophagitis. Neurogastroenterol Motil. 2016 Nov;28(11):1714-1722. doi: 10.1111/nmo.12872. Epub 2016 Jun 2.

  PMID: 27254480 BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gary W Falk, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 17, 2020
• Study Start: August 5, 2020
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)