HRIM vs Mucosal Impedance in GERD Participants
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|ClinicalTrials.gov Identifier: NCT02812407|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastro-esophageal Reflux Disease (GERD)||Device: Mucosal Impedance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Mucosal Impedance
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.
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.
Other Name: Impedance
- The mean impedance [ Time Frame: 2 years ]The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
- Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value [ Time Frame: 2 years ]Evaluate the measurement of HRIM and mucosal impedance in patients that did not show gastroesophageal reflux disease per the HRIM and impedance testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812407
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Karthik Ravi, MD||Mayo Clinic|