HRIM vs Mucosal Impedance in GERD Participants

Gastro-esophageal Reflux Disease (GERD) Clinical Trial

Official title:

Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02812407
• Other study ID #: 16-003580
• Status: Withdrawn
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does baseline impedance measured during the landmark phase of esophageal High resolution impedance manometry HRIM correlates with direct mucosal impedance measurement and discriminates GERD from non GERD patients?

Description:

Patients referred to the Mayo Clinic Rochester for a clinically indicated high resolution impedance manometry (HRIM), 24 hour impedance pH (MII-pH) study, and esophagogastroduodenoscopy (EGD) will be recruited. Gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant Proton Pump inhibitor (PPI) use. A negative 24 hour MII-pH study will be defined as an acid exposure time ≤2% off PPI therapy or ≤1% if on PPI therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Patients being seen at Mayo clinic Rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study.

Inclusion criteria:

• Adults ages 18-90

• Patients scheduled for or have completed a HRIM ( within 5 days)

• Patients scheduled for or recently have completed a MII-pH studies ( within 5 days)

• Patients scheduled for EGD

Exclusion criteria:

• Technically limited esophageal HRIM or MII-pH study

• Patients with HRIM and MII-pH studies not performed within 5 days of each other

• Patients with EGD not performed within 30 days of HRIM and MII-pH studies

• Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy

• Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Related Conditions & MeSH terms

• Gastro-esophageal Reflux Disease (GERD)
• Gastroesophageal Reflux

Intervention

Device:
• Mucosal Impedance
During the clinical endoscopy, the 2.13 mm catheter will be passed through the channel of the standard endoscope this is called an Intraluminal Impedance. The Intraluminal impedance (made by Sandhill Scientific) 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 gives the investigators a reading at each level. The catheter will be placed on the esophageal mucosa 5 cm above the gastroesophageal junction (where the stomach and esophagus meet) for 5 second At 10 cm above the gastroesophageal junction the catheter will be placed for 5 seconds And at 20 cm

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean impedance	The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD	2 years
Secondary	Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value	Evaluate the measurement of HRIM and mucosal impedance in patients that did not show gastroesophageal reflux disease per the HRIM and impedance testing	2 years

External Links

•   Mayo Clinic Clinical Trials