NCT02812407

HRIM vs Mucosal Impedance in GERD Participants

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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?

Detailed 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.

Conditions

• Gastro-esophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-06-24
• Last updated: 2020-06-09

Locations

1 site across 1 country: United States