HRIM vs Mucosal Impedance in GERD Participants

Mayo Clinic

Status: Withdrawn

Conditions: Gastro-esophageal Reflux Disease (GERD)

Treatments: Device: Mucosal Impedance

Study type: Interventional

Funder types: Other

Identifiers

NCT02812407

16-003580

Details and patient eligibility

About

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?

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Mucosal Impedance

Experimental group

Description:

Patient's having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study. 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. 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.

Treatment:

Device: Mucosal Impedance