Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339801
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-19
Brief Title:
Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
Sponsor:
Hospital de Clinicas José de San Martín
Organization:
Hospital de Clinicas José de San Martín
Study Overview
Official Title:
Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity Upper gastrointestinal endoscopy is highly specific for diagnosing GERD particularly when erosive esophagitis is present Los Angeles Classification B C or D Nevertheless its sensitivity is limited as this scenario is only present in 30 of cases Most patients will exhibit normal endoscopic findings indicating Non-Erosive Reflux Disease NERD The 24-hour impedance-pH monitoring MII is currently considered the gold standard However its main limitation is that it can only measure reflux activity over a 24-hour period in addition to the discomfort caused by the catheter 6-8 It is noteworthy that 50 of patients with NERD will have pathological reflux and the other 50 will have a sensory disorder The importance of making an accurate diagnosis lies in the treatment which varies in each case11 Recently a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance This serves as a tool for evaluating tissue changes associated with chronic reflux However this device has recently undergone improvements This new technology has not been tested yet for GERD diagnosis The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation
Objectives
The Main objectives of this study are to
1 Evaluate the diagnostic performance of mucosal impedance measurement
2 Investigate the mucosal impedance pattern in patients with and without GERD
Secondary objectives
1 Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2 Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective cross-sectional and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin University of Buenos Aires Argentina Following a 4-week screening period during which a proton pump inhibitor PPI washout will be performed and baseline measurements will be taken all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedancepH monitoring
Objectives
The Main objectives of this study are to
1 Evaluate the diagnostic performance of mucosal impedance measurement
2 Investigate the mucosal impedance pattern in patients with and without GERD
Secondary objectives
1 Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2 Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective cross-sectional and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin University of Buenos Aires Argentina Following a 4-week screening period during which a proton pump inhibitor PPI washout will be performed and baseline measurements will be taken all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedancepH monitoring
Detailed Description:
Gastroesophageal Reflux Disease GERD occurs when gastroduodenal content refluxes causing bothersome symptoms andor complications 1 It is estimated that GERD affects 20-30 of the population in Western countries 2 23 in Argentina and it is associated with an impairment in the quality of life and significant healthcare costs 3-5 Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity Upper gastrointestinal endoscopy is highly specific for diagnosing GERD particularly when erosive esophagitis is present Los Angeles Classification B C or D Nevertheless its sensitivity is limited as this scenario is only present in 30 of cases Most patients will exhibit normal endoscopic findings indicating Non-Erosive Reflux Disease NERD The 24-hour impedance-pH monitoring MII is currently considered the gold standard However its main limitation is that it can only measure reflux activity over a 24-hour period in addition to the discomfort caused by the catheter 6-8 The last Lyon Consensus considered GERD when erosive esophagitis is present Los Angeles Classification B C or D or acid exposure time AET is ampgt6 on ambulatory studies Acid exposure time amplt4 definitively rules out pathologic gastroesophageal acid reflux while AET between 4-6 is considered borderline 910 It is noteworthy that 50 of patients with NERD will have pathological reflux and the other 50 will have a sensory disorder The importance of making an accurate diagnosis lies in the treatment which varies in each case11 Recently a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance This serves as a tool for evaluating tissue changes associated with chronic reflux12 However this device has recently undergone improvements This new technology has not been tested yet for GERD diagnosis The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation
Objectives
The Main objectives of this study are to
1 Evaluate the diagnostic performance of mucosal impedance measurement
2 Investigate the mucosal impedance pattern in patients with and without GERD
Secondary objectives
1 Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2 Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective cross-sectional and analytical study METHODS Participants Interventions and Outcomes Study Setting Inclusion Criteria Patients ampgt18 years presenting symptoms of GERD that have not adequately responded to proton pump inhibitors PPIs treatment after 8 weeks and have undergone upper gastrointestinal endoscopy UGIE without erosive esophagitis
Patients with a broad spectrum of severity assessed through the GERDq score will be included Exclusion Criteria
Pregnancy or lactation
Esophageal disorders esophageal motor disorders eosinophilic esophagitis neoplastic diseases
Uncontrolled systemic diseases diabetes mellitus hypo- or hyperthyroidism cancer etc
Lack of informed consent
Severe psychiatric disorders Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin University of Buenos Aires Argentina Following a 4-week screening period during which a proton pump inhibitor PPI washout will be performed and baseline measurements will be taken all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedancepH monitoring
Intervention All patients will undergo mucosal impedance MI measurement using the MiVu Mucosal Integrity Testing System Diversatek Healthcare Inc The MiVu Mucosal Integrity Testing System utilizes a device MiVu Endo Cap that attaches to the distal end of the endoscope along with proprietary software to instantly detect changes in esophageal mucosal integrity during endoscopy Patients are required to fast for 8 hours before the procedure During an upper gastrointestinal endoscopy under anesthesia sedation measurements are taken from direct contact of the sensors with the esophageal mucosa Any luminal air or liquid between the sensors and mucosal tissue will be pressed away from the tissue being measured After identifying the gastroesophageal junction measurements will be initiated 2cm above it The endoscopist will wait until all 3 sensors make stable contact with the mucosa indicated by high-quality signals marked in green color by the software The Study Metrics require data spanning 10 consecutive centimeters Each measurement capture will span 3 cm and a minimum of 4 measurements spanning 10 cm are required Once measurements have been captured at 4 depths the metrics will populate MI measurements will be expressed in Ohms and analyzed using the ZVU software version 33 or greater Diversatek Healthcare Inc Once 10 centimeters worth of consecutive data have been acquired the probabilities of disease will be displayed and patients will be categorized as 1 NERD and 2 Non-NERD based on the measurement result The results will be expressed in Ohms and the interpretation will be based on the results from table 2 in the previous MI validation publication14 Subsequently a 24-hour impedancepH monitoring without proton pump inhibitors PPI preceded by high-resolution esophageal manometry to identify the lower esophageal sphincter height will be performed Both assessments will be conducted by different operators in a blind and independent manner
Patients will be divided into two groups A NERD when the percentage of time of acid exposure is greater than 6 B Non-NERD when the percentage of acid exposure is less than 4 The Demeester score will be reported for both groups
Treatment response evaluation
Based on the previously described categorization the following treatment will be initiated
1 Dexlansoprazole 30mg per day in the GERD group
2 Amitriptyline 10mg per day in the non-GERD group At 8 weeks post-treatment a GerdQ assessment will be conducted Sample Size Considering an estimated sensitivity of mucosal impedance measurement for the diagnosis of GERD of 70 a sample size of 100 patients was calculated Factoring in a 20 patient loss a total of 120 patients will be screened
Objectives
The Main objectives of this study are to
1 Evaluate the diagnostic performance of mucosal impedance measurement
2 Investigate the mucosal impedance pattern in patients with and without GERD
Secondary objectives
1 Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2 Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective cross-sectional and analytical study METHODS Participants Interventions and Outcomes Study Setting Inclusion Criteria Patients ampgt18 years presenting symptoms of GERD that have not adequately responded to proton pump inhibitors PPIs treatment after 8 weeks and have undergone upper gastrointestinal endoscopy UGIE without erosive esophagitis
Patients with a broad spectrum of severity assessed through the GERDq score will be included Exclusion Criteria
Pregnancy or lactation
Esophageal disorders esophageal motor disorders eosinophilic esophagitis neoplastic diseases
Uncontrolled systemic diseases diabetes mellitus hypo- or hyperthyroidism cancer etc
Lack of informed consent
Severe psychiatric disorders Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin University of Buenos Aires Argentina Following a 4-week screening period during which a proton pump inhibitor PPI washout will be performed and baseline measurements will be taken all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedancepH monitoring
Intervention All patients will undergo mucosal impedance MI measurement using the MiVu Mucosal Integrity Testing System Diversatek Healthcare Inc The MiVu Mucosal Integrity Testing System utilizes a device MiVu Endo Cap that attaches to the distal end of the endoscope along with proprietary software to instantly detect changes in esophageal mucosal integrity during endoscopy Patients are required to fast for 8 hours before the procedure During an upper gastrointestinal endoscopy under anesthesia sedation measurements are taken from direct contact of the sensors with the esophageal mucosa Any luminal air or liquid between the sensors and mucosal tissue will be pressed away from the tissue being measured After identifying the gastroesophageal junction measurements will be initiated 2cm above it The endoscopist will wait until all 3 sensors make stable contact with the mucosa indicated by high-quality signals marked in green color by the software The Study Metrics require data spanning 10 consecutive centimeters Each measurement capture will span 3 cm and a minimum of 4 measurements spanning 10 cm are required Once measurements have been captured at 4 depths the metrics will populate MI measurements will be expressed in Ohms and analyzed using the ZVU software version 33 or greater Diversatek Healthcare Inc Once 10 centimeters worth of consecutive data have been acquired the probabilities of disease will be displayed and patients will be categorized as 1 NERD and 2 Non-NERD based on the measurement result The results will be expressed in Ohms and the interpretation will be based on the results from table 2 in the previous MI validation publication14 Subsequently a 24-hour impedancepH monitoring without proton pump inhibitors PPI preceded by high-resolution esophageal manometry to identify the lower esophageal sphincter height will be performed Both assessments will be conducted by different operators in a blind and independent manner
Patients will be divided into two groups A NERD when the percentage of time of acid exposure is greater than 6 B Non-NERD when the percentage of acid exposure is less than 4 The Demeester score will be reported for both groups
Treatment response evaluation
Based on the previously described categorization the following treatment will be initiated
1 Dexlansoprazole 30mg per day in the GERD group
2 Amitriptyline 10mg per day in the non-GERD group At 8 weeks post-treatment a GerdQ assessment will be conducted Sample Size Considering an estimated sensitivity of mucosal impedance measurement for the diagnosis of GERD of 70 a sample size of 100 patients was calculated Factoring in a 20 patient loss a total of 120 patients will be screened
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None