HRIM vs Mucosal Impedance in GERD Participants

NCT02812407 | Withdrawn

• 1 other identifier: 16-003580
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• The mean impedance

  The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD

  2 years

Secondary Outcomes (1)

• Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value

  2 years

Study Arms (1)

Mucosal Impedance

EXPERIMENTAL

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

Interventions

Mucosal Impedance DEVICE

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

Also known as: Impedance

Mucosal Impedance

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Karthik Ravi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 24, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 9, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)