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Mucosal Impedance and Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT01953575
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 26, 2013
First Posted Date  ICMJE October 1, 2013
Last Update Posted Date November 9, 2018
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy. [ Time Frame: basesline to one year ]
As a pilot, ten patients will be studied before and after treatment for eosinophilic esophagitis. This number of patients will be increased if there are treatment failures until there is a total of ten effectively treated patients studied. Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy. Ten control patients without esophageal disease will be studied.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01953575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Mucosal Impedance and Eosinophilic Esophagitis
Official Title  ICMJE Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Brief Summary

Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?

And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE Device: Mucosal Impedance

Mucosal impedance- a (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds.

  • At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds
  • And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds.

This will determine if people with eosinophilic esophagitis (EoE) have an increased esophageal mucosa impedance (food getting into the esophageal tissue).

Other Names:
  • ph impedance
  • ph monitor
Study Arms Experimental: Mucosal Impedance

Patients with Eosinophilic Esophagitis and patient without trouble swallowing,during your clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. This device has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it.

  • The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds.
  • At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds
  • And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds.
Intervention: Device: Mucosal Impedance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2014)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
20
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01953575
Other Study ID Numbers  ICMJE 13-005778
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David A. Katzka, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Katzka, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP