Gastro-esophageal Reflux Disease (GERD)NCT02812407
HRIM vs Mucosal Impedance in GERD Participants
A study testing Mucosal Impedance in people with Gastro-esophageal Reflux Disease (GERD), run by Mayo Clinic at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastro-esophageal Reflux Disease (GERD)
- What is being tested?
- Mucosal Impedance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
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?
Read the 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)
- Being tested
- Mucosal Impedance
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosal ImpedanceDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mucosal Impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean impedance
The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
Measured: 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
Evaluate the measurement of HRIM and mucosal impedance in patients that did not show gastroesophageal reflux disease per the HRIM and impedance testing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: No linger a clinically relevant research question
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Ravi, M.D., Mayo Clinic
- Investigators
- Karthik Ravi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812407
- Sponsor's protocol ID
- 16-003580
- Status last verified
- Sep 2019
- First submitted
- 20 Jun 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Impedance Measured on High Resolution Esophageal Impedance Manometry to Discriminate GERD From Non GERD Patients
- ClinicalTrials.gov ID
- NCT02812407
- Acronym / sponsor ID
- 16-003580
- Conditions
- Gastro-esophageal Reflux Disease (GERD)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No linger a clinically relevant research question
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucosal Impedance | Experimental | Device: Mucosal ImpedancePatient'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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucosal ImpedanceAlso: ImpedanceDuring 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 | Device | Mucosal Impedance |
Primary outcome
The mean impedance
Time frame: 2 years
The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthik Ravi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucosal Impedance in people with Gastro-esophageal Reflux Disease (GERD), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean impedance (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.