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Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02995395
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : February 3, 2021
Sponsor:
Collaborator:
Sandhill Scientific
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Brief Summary:
This study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Healthy Device: Mucosal Impedance Balloon catheter

Detailed Description:

The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies. Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect of treatment" using a new technology allowing for direct assessment of mucosal impedance at the time of routine upper endoscopy to assess esophageal integrity and disease activity and alevate the need for biopsies.

For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly to provide precise measurements over a broad area of esophageal epithelium, while eliminating the fluids and spanning across a 10 mm luminal area using the same direct assessment as the mucosal impedance at the time of routine upper endoscopy.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mucosal Impedance Balloon catheter
At the conclusion of the endoscopy, all fluids will be aspirated from the esophagus. The endoscope will then be left in place in the mid-esophagus and a custom Mucosal Impedance (MI) balloon assembly four axial arrays of 10 sensors (total of 40 sensors) will be positioned along the esophageal mucosal wall under direct visualization to directly measure MI at uniform intervals. Once in place, impedance readings will be recorded for a total of 2 minutes. At this point both the endoscope and impedance catheter will be withdrawn simultaneously.
Device: Mucosal Impedance Balloon catheter

During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.

o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded.

Other Name: Impedance balloon testing




Primary Outcome Measures :
  1. Diminished mucosal impedance in patients with Eosinophilic Esophagitis [ Time Frame: 1 year ]
    Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Eosinophilic Esophagitis having an upper endoscopy. Patients having an upper endoscopy for dysphagia or GERD
Criteria

Inclusion criteria:

  • Adults ages 18-90 undergoing clinically indicated upper endoscopy
  • Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
  • Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.

Exclusion criteria:

  • Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
  • Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995395


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Sandhill Scientific
Investigators
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Principal Investigator: David A Katzka Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02995395    
Other Study ID Numbers: 16-005863
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases