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HRIM vs Mucosal Impedance in GERD Participants

NCT02812407 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-06-09

No results posted yet for this study

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?

Conditions

  • Gastro-esophageal Reflux Disease (GERD)

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Karthik Ravi, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02812407 on ClinicalTrials.gov