Utility of Mucosal Impedance Device in Chronic Esophageal Disorders:
NCT ID: NCT07227506
Last Updated: 2025-11-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-11-20
Study Completion Date
2028-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Background \& Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as we might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same patient for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making.
Aim:
Here, we will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in patients with reflux symptoms or chronic esophageal symptoms.
Aim:
Here, we will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in patients with reflux symptoms or chronic esophageal symptoms.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Diagnostic Utility of Mucosal Impedance Device in patients with GERD and chronic esophageal disorders:
Background \& Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as we might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same patient for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making.
In summary, current diagnostic testing for GERD lead to several challenges:
* Delayed diagnosis, particularly in cases where patients undergo normal endoscopy but still experience symptoms.
* Increased healthcare costs, with GERD alone accounting for an estimated $24 billion annually in the United States.
* Diagnostic overlap between GERD and EoE, which complicates clinical decision-making and contributes to further delays or misdiagnoses.
Since majority of the patients who undergo upper endoscopy for GERD, have normal endoscopic visualization of esophagus, esophageal pH impedance or wireless pH testing are essential to make the diagnosis of GERD. Hence, Esophageal Mucosal impedance (Mivu) is a measurement tool that can evaluate if the structure of the esophageal mucosal tissue as a one-stop solution testing. MI is performed using an FDA approved endoscopic tool called "Mucosal Integrity Conductivity Test System" (Diversatek). The Mivu system software uses the collected data to determine if there is evidence of GERD.
Prior studies have demonstrated a positive correlation between low mucosal impedance and conditions such as GERD and EoE. As such, Mivu offers the potential to:
* Serve as a single-procedure diagnostic approach.
* Reduce diagnostic delay and resource utilization.
* Improve accuracy in differentiating between GERD, EoE, and functional heartburn.
Aim:
Here, we will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in patients with reflux symptoms or chronic esophageal symptoms.
Methods:
Study:
This is a prospective study aimed at evaluating chronic benign esophageal disorders such as gastroesophageal reflux disease and eosinophilic esophagitis. All the patients with reflux symptoms or dysphagia/esophageal symptoms who undergo upper endoscopy will be enrolled into the study.
Study Population:
Inclusion Criteria:
1\. Patients with chronic esophageal symptoms such as atypical or typical reflux symptoms and dysphagia, is here for upper endoscopy testing.
Exclusion Criteria:
1. Presence of esophageal stricture
2. Unstable patients who cannot undergo this testing.
3. Patients on anticoagulation on the day of procedure.
4. Presence of esophageal cancer.
5. Pregnancy.
6. Minor patients.
Step by Step Procedure:
1. During routine esophagogastroduodenoscopy (EGD) visit, consented study participants will be given GERD questionnaire.
2. During endoscopic evaluation of the esophagus as a part of standard of care, we will make sure there is no esophageal stricture or malignancy.
3. Subsequently, original single channel Mivu catheter (FDA approved) advanced to the distal esophagus.
4. Measurements of mucosal impedance will be taken at proximal, mid and distal esophageal locations for 5 seconds each.
5. Once the mucosal impedance data have been recorded, the assembly will be deflated and removed by the investigator.
6. The study procedure will add approximately 1-5 minutes of procedure time for each research participant.
7. Patients will undergo further diagnostic testing as per standard of care.
8. Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care.
Clinical Parameters that will be collected:
Clinical:
1. Demographics (age, sex, race, and body mass index).
2. GERD questionnaire.
3. Dysphagia symptom severity using Mayo Dysphagia Scale and hypervigilance questionnaire.
Endoscopic:
1. Presence and size of a hiatal hernia.
2. Presence and severity of esophagitis (graded by the Los Angeles Classification: A, B, C, or D).
3. Novel Mucosal impedance data: proximal and distal esophageal sensor.
4. Endoflip data if done as part of standard of care- esophageal distensibility index.
5. Standard esophageal pH and impedance testing if done as part of standard of care: Proximal and distal acid exposure times over the study period, nocturnal basal impedance.
6. Pathology Data if done as part of standard of care: Eosinophil count (proximal and distal esophageal counts).
7. Esophageal manometry if done as part of standard of care: esophageal contractility integral, relaxation of lower esophageal sphincters.
Clinical Outcomes:
1. Diagnostic utility of mucosal impedance in the diagnosis of GERD; correlation of esophageal pH parameters with mucosal impedance data.
2. Cost-effectiveness of Mivu compared to the standard diagnostic testing tools such as esophageal pH or Bravo testing.
3. Correlation of esophageal inflammation in benign esophageal inflammatory disorders such as eosinophilic esophagitis and mucosal impedance values from Mivu.
Analysis:
This study will compare questionnaire scores and mucosal impedance scores in patients with GERD. All the categorical and numerical variables will be compared by Fischer's exact and Mann-Whitney test, respectively. Diagnostic utility (sensitivity and specificity of the new Mivu device will be calculated against the gold standard- endoscopy and esophageal pH testing. Sample size calculation after initial data collection of 50 patients.
Risks and Benefits
Risks:
Minimal risk from surveys and medical record review Confidentiality breaches (mitigated by de-identification and secure storage)
Benefits:
No direct benefit, but participants may receive closer monitoring and contribute to improving GERD management.
Recruitment Strategy:
All GERD patients and patients with esophageal symptoms who are coming to the endoscopic lab at Froedtert Hospital as part of their clinical care, will be offered the option of new FDA (Mivu) approved device in evaluation of GERD.
Informed Consent Process GERD patients will be informed of the study's purpose, procedures, risks, and benefits. Consent will be obtained prior to any study activity and documented per IRB requirements.
Possible Risks to Study Subjects due to Mivu Device:
Physical Risks:
Most common: Coughing, gagging after the procedure, sore throat. Least common: Vomiting, self-limiting oral or esophageal bleeds. Rare: esophageal tear or perforation(although not seen in prior reported studies).
Confidentiality and Privacy Risks: Patient information will only be accessible to the research team for the needed data. Information will be physically secured through locked facilities and stored on approved encrypted devices.
Procedures to Minimize Risks of the study subjects:
1. Recruitment Strategy: We aim to recruit patients with reflux and esophageal symptoms. Before enrollment into this study all the subjects will be scrutinized for inclusion and exclusion criteria utilized during the interview process.
2. Procedure: All the procedures will be conducted under the supervision of the Principal Investigator/Co-investigators and his research team in the Endoscopy suite in Froedtert Memorial Lutheran Hospital.
Mivu Mucosal Impedance Device: A qualified physician (Gastroenterologist) will be performing this procedure at the time of endoscopy as a part of standard of care. It is done only on subjects with a patent esophageal and pharyngeal lumen (no strictures). The subjects are intubated on an examination table with prior endoscopic evaluation to minimize any esophageal or pharyngeal trauma. Subjects will be asked to be NPO for 6 hours prior to their visit as a part of the standard of care. In addition, care would be taken to reduce the risk of bleeding by stopping anticoagulation prior to the procedure as a part of standard of care.
Appendices Informed Consent Form GERD Questionnaire Data Collection Forms
References:
Maresova, P., Rezny, L., Hruska, J. et al. Diagnosis and treatment of patients with gastroesophageal reflux disease - a systematic review of cost-effectiveness and economic burden. BMC Health Serv Res 24, 1351 (2024). https://doi.org/10.1186/s12913-024-11781-8.
Patel, D. A., Higginbotham, T., Slaughter, J. C., Aslam, M., Yuksel, E., Katzka, D., ... \& Vaezi, M. F. (2019). Development and validation of a mucosal impedance contour analysis system to distinguish esophageal disorders. Gastroenterology, 156(6), 1617-1626.
Choksi, Y., Lal, P., Slaughter, J.C., Sharda, R., Parnell, J., Higginbotham, T. and Vaezi, M.F., 2018. Esophageal mucosal impedance patterns discriminate patients with eosinophilic esophagitis from patients with GERD. Clinical Gastroenterology and Hepatology, 16(5), pp.664-671.
Yuksel, E.S., Higginbotham, T., Slaughter, J.C., Mabary, J., Kavitt, R.T., Garrett, C.G. and Vaezi, M.F., 2012. Use of direct, endoscopic-guided measurements of mucosal impedance in diagnosis of gastroesophageal reflux disease. Clinical Gastroenterology and Hepatology, 10(10), pp.1110-1116.
Gyawali CP, Yadlapati R, Fass R, Katzka D, Pandolfino J, Savarino E, Sifrim D, Spechler S, Zerbib F, Fox MR, Bhatia S. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024 Feb 1;73(2):361-71.
Background \& Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as we might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same patient for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making.
In summary, current diagnostic testing for GERD lead to several challenges:
* Delayed diagnosis, particularly in cases where patients undergo normal endoscopy but still experience symptoms.
* Increased healthcare costs, with GERD alone accounting for an estimated $24 billion annually in the United States.
* Diagnostic overlap between GERD and EoE, which complicates clinical decision-making and contributes to further delays or misdiagnoses.
Since majority of the patients who undergo upper endoscopy for GERD, have normal endoscopic visualization of esophagus, esophageal pH impedance or wireless pH testing are essential to make the diagnosis of GERD. Hence, Esophageal Mucosal impedance (Mivu) is a measurement tool that can evaluate if the structure of the esophageal mucosal tissue as a one-stop solution testing. MI is performed using an FDA approved endoscopic tool called "Mucosal Integrity Conductivity Test System" (Diversatek). The Mivu system software uses the collected data to determine if there is evidence of GERD.
Prior studies have demonstrated a positive correlation between low mucosal impedance and conditions such as GERD and EoE. As such, Mivu offers the potential to:
* Serve as a single-procedure diagnostic approach.
* Reduce diagnostic delay and resource utilization.
* Improve accuracy in differentiating between GERD, EoE, and functional heartburn.
Aim:
Here, we will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in patients with reflux symptoms or chronic esophageal symptoms.
Methods:
Study:
This is a prospective study aimed at evaluating chronic benign esophageal disorders such as gastroesophageal reflux disease and eosinophilic esophagitis. All the patients with reflux symptoms or dysphagia/esophageal symptoms who undergo upper endoscopy will be enrolled into the study.
Study Population:
Inclusion Criteria:
1\. Patients with chronic esophageal symptoms such as atypical or typical reflux symptoms and dysphagia, is here for upper endoscopy testing.
Exclusion Criteria:
1. Presence of esophageal stricture
2. Unstable patients who cannot undergo this testing.
3. Patients on anticoagulation on the day of procedure.
4. Presence of esophageal cancer.
5. Pregnancy.
6. Minor patients.
Step by Step Procedure:
1. During routine esophagogastroduodenoscopy (EGD) visit, consented study participants will be given GERD questionnaire.
2. During endoscopic evaluation of the esophagus as a part of standard of care, we will make sure there is no esophageal stricture or malignancy.
3. Subsequently, original single channel Mivu catheter (FDA approved) advanced to the distal esophagus.
4. Measurements of mucosal impedance will be taken at proximal, mid and distal esophageal locations for 5 seconds each.
5. Once the mucosal impedance data have been recorded, the assembly will be deflated and removed by the investigator.
6. The study procedure will add approximately 1-5 minutes of procedure time for each research participant.
7. Patients will undergo further diagnostic testing as per standard of care.
8. Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care.
Clinical Parameters that will be collected:
Clinical:
1. Demographics (age, sex, race, and body mass index).
2. GERD questionnaire.
3. Dysphagia symptom severity using Mayo Dysphagia Scale and hypervigilance questionnaire.
Endoscopic:
1. Presence and size of a hiatal hernia.
2. Presence and severity of esophagitis (graded by the Los Angeles Classification: A, B, C, or D).
3. Novel Mucosal impedance data: proximal and distal esophageal sensor.
4. Endoflip data if done as part of standard of care- esophageal distensibility index.
5. Standard esophageal pH and impedance testing if done as part of standard of care: Proximal and distal acid exposure times over the study period, nocturnal basal impedance.
6. Pathology Data if done as part of standard of care: Eosinophil count (proximal and distal esophageal counts).
7. Esophageal manometry if done as part of standard of care: esophageal contractility integral, relaxation of lower esophageal sphincters.
Clinical Outcomes:
1. Diagnostic utility of mucosal impedance in the diagnosis of GERD; correlation of esophageal pH parameters with mucosal impedance data.
2. Cost-effectiveness of Mivu compared to the standard diagnostic testing tools such as esophageal pH or Bravo testing.
3. Correlation of esophageal inflammation in benign esophageal inflammatory disorders such as eosinophilic esophagitis and mucosal impedance values from Mivu.
Analysis:
This study will compare questionnaire scores and mucosal impedance scores in patients with GERD. All the categorical and numerical variables will be compared by Fischer's exact and Mann-Whitney test, respectively. Diagnostic utility (sensitivity and specificity of the new Mivu device will be calculated against the gold standard- endoscopy and esophageal pH testing. Sample size calculation after initial data collection of 50 patients.
Risks and Benefits
Risks:
Minimal risk from surveys and medical record review Confidentiality breaches (mitigated by de-identification and secure storage)
Benefits:
No direct benefit, but participants may receive closer monitoring and contribute to improving GERD management.
Recruitment Strategy:
All GERD patients and patients with esophageal symptoms who are coming to the endoscopic lab at Froedtert Hospital as part of their clinical care, will be offered the option of new FDA (Mivu) approved device in evaluation of GERD.
Informed Consent Process GERD patients will be informed of the study's purpose, procedures, risks, and benefits. Consent will be obtained prior to any study activity and documented per IRB requirements.
Possible Risks to Study Subjects due to Mivu Device:
Physical Risks:
Most common: Coughing, gagging after the procedure, sore throat. Least common: Vomiting, self-limiting oral or esophageal bleeds. Rare: esophageal tear or perforation(although not seen in prior reported studies).
Confidentiality and Privacy Risks: Patient information will only be accessible to the research team for the needed data. Information will be physically secured through locked facilities and stored on approved encrypted devices.
Procedures to Minimize Risks of the study subjects:
1. Recruitment Strategy: We aim to recruit patients with reflux and esophageal symptoms. Before enrollment into this study all the subjects will be scrutinized for inclusion and exclusion criteria utilized during the interview process.
2. Procedure: All the procedures will be conducted under the supervision of the Principal Investigator/Co-investigators and his research team in the Endoscopy suite in Froedtert Memorial Lutheran Hospital.
Mivu Mucosal Impedance Device: A qualified physician (Gastroenterologist) will be performing this procedure at the time of endoscopy as a part of standard of care. It is done only on subjects with a patent esophageal and pharyngeal lumen (no strictures). The subjects are intubated on an examination table with prior endoscopic evaluation to minimize any esophageal or pharyngeal trauma. Subjects will be asked to be NPO for 6 hours prior to their visit as a part of the standard of care. In addition, care would be taken to reduce the risk of bleeding by stopping anticoagulation prior to the procedure as a part of standard of care.
Appendices Informed Consent Form GERD Questionnaire Data Collection Forms
References:
Maresova, P., Rezny, L., Hruska, J. et al. Diagnosis and treatment of patients with gastroesophageal reflux disease - a systematic review of cost-effectiveness and economic burden. BMC Health Serv Res 24, 1351 (2024). https://doi.org/10.1186/s12913-024-11781-8.
Patel, D. A., Higginbotham, T., Slaughter, J. C., Aslam, M., Yuksel, E., Katzka, D., ... \& Vaezi, M. F. (2019). Development and validation of a mucosal impedance contour analysis system to distinguish esophageal disorders. Gastroenterology, 156(6), 1617-1626.
Choksi, Y., Lal, P., Slaughter, J.C., Sharda, R., Parnell, J., Higginbotham, T. and Vaezi, M.F., 2018. Esophageal mucosal impedance patterns discriminate patients with eosinophilic esophagitis from patients with GERD. Clinical Gastroenterology and Hepatology, 16(5), pp.664-671.
Yuksel, E.S., Higginbotham, T., Slaughter, J.C., Mabary, J., Kavitt, R.T., Garrett, C.G. and Vaezi, M.F., 2012. Use of direct, endoscopic-guided measurements of mucosal impedance in diagnosis of gastroesophageal reflux disease. Clinical Gastroenterology and Hepatology, 10(10), pp.1110-1116.
Gyawali CP, Yadlapati R, Fass R, Katzka D, Pandolfino J, Savarino E, Sifrim D, Spechler S, Zerbib F, Fox MR, Bhatia S. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024 Feb 1;73(2):361-71.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Gerd
Eosinophilic Esophagitis
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
gerd
eosinophilic esophagitis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
True GERD
Positive endoscopy findings or esophageal pH results based on Lyon 2.0
MuVI Esophageal mucosal impedance testing
Intervention Type
DEVICE
Esophageal mucosal impedance values are checked in both groups
Functional Heartburn
Negative endoscopy and negative esophageal pH testing results
MuVI Esophageal mucosal impedance testing
Intervention Type
DEVICE
Esophageal mucosal impedance values are checked in both groups
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MuVI Esophageal mucosal impedance testing
Esophageal mucosal impedance values are checked in both groups
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1\. Patients with chronic esophageal symptoms such as atypical or typical reflux symptoms and dysphagia, is here for upper endoscopy testing.
Exclusion Criteria
1. Presence of esophageal stricture
2. Unstable patients who cannot undergo this testing.
3. Patients on anticoagulation on the day of procedure.
4. Presence of esophageal cancer.
5. Pregnancy.
6. Minor patients.
2. Unstable patients who cannot undergo this testing.
3. Patients on anticoagulation on the day of procedure.
4. Presence of esophageal cancer.
5. Pregnancy.
6. Minor patients.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical College of Wisconsin
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gokulakrishnan Balasubramanian
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Froedtert Hospital
Milwaukee, Wisconsin, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gokulakrishnan Balasubramanian, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Choksi Y, Lal P, Slaughter JC, Sharda R, Parnell J, Higginbotham T, Vaezi MF. Esophageal Mucosal Impedance Patterns Discriminate Patients With Eosinophilic Esophagitis From Patients With GERD. Clin Gastroenterol Hepatol. 2018 May;16(5):664-671.e1. doi: 10.1016/j.cgh.2017.12.020. Epub 2017 Dec 14.
Reference Type
RESULT
Patel DA, Higginbotham T, Slaughter JC, Aslam M, Yuksel E, Katzka D, Gyawali CP, Mashi M, Pandolfino J, Vaezi MF. Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders. Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.
Reference Type
RESULT
Maresova P, Rezny L, Hruska J, Klimova B, Swanstrom LL, Kuca K. Diagnosis and treatment of patients with gastroesophageal reflux disease - a systematic review of cost-effectiveness and economic burden. BMC Health Serv Res. 2024 Nov 6;24(1):1351. doi: 10.1186/s12913-024-11781-8.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO00055595
Identifier Type: -
Identifier Source: org_study_id