Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613438
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease GERD Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease GERD
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to evaluate the safety and effectiveness of the eGERD device which is a novel device for treating Gastroesophageal Reflux Disease GERD
The main questions this research aims to answer are
1 Does the eGERD device reduce acidity in the esophagus
2 Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation
3 What medical problems do participants have when using the eGERD device
To assess the acidity in the esophagus a wireless standard-of-care capsule called Bravo will be placed in the participants esophagus throat for several days
To assess GERD symptoms participants will be requested to report symptoms they experience using a smartphone application
Researchers will compare a real version of the eGERD device to a sham version a look-alike device that has no therapeutic effect to see if the eGERD device is effective in treating GERD
The main questions this research aims to answer are
1 Does the eGERD device reduce acidity in the esophagus
2 Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation
3 What medical problems do participants have when using the eGERD device
To assess the acidity in the esophagus a wireless standard-of-care capsule called Bravo will be placed in the participants esophagus throat for several days
To assess GERD symptoms participants will be requested to report symptoms they experience using a smartphone application
Researchers will compare a real version of the eGERD device to a sham version a look-alike device that has no therapeutic effect to see if the eGERD device is effective in treating GERD
Detailed Description:
The study includes two consecutive phases a 14-day washout phase followed by a 28-day device treatment phase
The washout phase starts on or shortly after the Screening visit in which the participants sign the informed consent form ICF and their eligibility criteria are assessed The first day of the washout phase is considered Day 1 of the study
In the washout phase participants are instructed to avoid any GERD-treatment medications including antacids either prescribed or over-the-counter OTC and to keep their regular daily routines
Participants are also instructed to report occurrence and severity of GERD-related symptoms using the eGERD smartphone application
GERD-HRQL questionnaire are filled at the onset Day 1 and at the end Day 14 of this phase Questionnaire score obtained at the end of the washout phase QoL Score baseline are regarded as baseline for the QoL secondary endpoint
On the last day of the washout phase Day 14 a 24h wireless pH monitoring test Bravo is initiated in order to obtain acid exposure time AET and DeMeester score DM baseline levels
The device treatment phase consists of continuous usage of the study device for 28 days
At the onset of the device treatment phase the pH monitoring data is downloaded and analyzed to establish AET and DM baseline levels To be eligible for randomization and study device usage a participant must have i at least 18 hours of baseline monitoring data and ii abnormal baseline AET above 6 Ineligible subjects are classified as screen failures participants with insufficient baseline monitoring data less than 18 monitoring hours are offered to extend the baseline monitoring for another 24 hours
Upon establishing participant eligibility and performing randomization a new 96h wireless pH monitoring test is initiated using the same Bravo capsule already in place At the same time the participant starts using the study device One day later a short clinic visit is held in which proper operation of the study device is verified At the end of the 96h pH monitoring test the monitoring system is collected and the data downloaded
Usage of the study device is continued from randomization for 28 days Esophageal acid exposure time AET and DeMeester score DM obtained from the 24h wireless pH monitoring test are regarded as baseline for AET primary endpoint and DeMeester score secondary endpoint respectively
Esophageal acid exposure time and DeMeester score obtained from the last Complete Monitoring Day of the 96h monitoring test are considered AET primary endpoint and DeMeester score secondary endpoint respectively
Throughout this phase participants are using a study device either functional or sham after receiving instructions on its usage Participants are instructed to use the study device 24 hours per day 7 days per week excluding device charging bathing sporting private situations etc
Usage of antacids Gaviscon Regular Strength antacid tablets 2-4 tablets up to 4 times a day as a rescue treatment is allowed after the Bravo system has been collected from the participant Day 19 Rescue treatment usage is reported and recorded Usage of any other type of GERD-treatment is prohibited throughout the entire phase
GERD-HRQL questionnaire is filled at the end of this phase or on end-of-study visit in case of early termination Resulting score is regarded as QoL secondary endpoint
The washout phase starts on or shortly after the Screening visit in which the participants sign the informed consent form ICF and their eligibility criteria are assessed The first day of the washout phase is considered Day 1 of the study
In the washout phase participants are instructed to avoid any GERD-treatment medications including antacids either prescribed or over-the-counter OTC and to keep their regular daily routines
Participants are also instructed to report occurrence and severity of GERD-related symptoms using the eGERD smartphone application
GERD-HRQL questionnaire are filled at the onset Day 1 and at the end Day 14 of this phase Questionnaire score obtained at the end of the washout phase QoL Score baseline are regarded as baseline for the QoL secondary endpoint
On the last day of the washout phase Day 14 a 24h wireless pH monitoring test Bravo is initiated in order to obtain acid exposure time AET and DeMeester score DM baseline levels
The device treatment phase consists of continuous usage of the study device for 28 days
At the onset of the device treatment phase the pH monitoring data is downloaded and analyzed to establish AET and DM baseline levels To be eligible for randomization and study device usage a participant must have i at least 18 hours of baseline monitoring data and ii abnormal baseline AET above 6 Ineligible subjects are classified as screen failures participants with insufficient baseline monitoring data less than 18 monitoring hours are offered to extend the baseline monitoring for another 24 hours
Upon establishing participant eligibility and performing randomization a new 96h wireless pH monitoring test is initiated using the same Bravo capsule already in place At the same time the participant starts using the study device One day later a short clinic visit is held in which proper operation of the study device is verified At the end of the 96h pH monitoring test the monitoring system is collected and the data downloaded
Usage of the study device is continued from randomization for 28 days Esophageal acid exposure time AET and DeMeester score DM obtained from the 24h wireless pH monitoring test are regarded as baseline for AET primary endpoint and DeMeester score secondary endpoint respectively
Esophageal acid exposure time and DeMeester score obtained from the last Complete Monitoring Day of the 96h monitoring test are considered AET primary endpoint and DeMeester score secondary endpoint respectively
Throughout this phase participants are using a study device either functional or sham after receiving instructions on its usage Participants are instructed to use the study device 24 hours per day 7 days per week excluding device charging bathing sporting private situations etc
Usage of antacids Gaviscon Regular Strength antacid tablets 2-4 tablets up to 4 times a day as a rescue treatment is allowed after the Bravo system has been collected from the participant Day 19 Rescue treatment usage is reported and recorded Usage of any other type of GERD-treatment is prohibited throughout the entire phase
GERD-HRQL questionnaire is filled at the end of this phase or on end-of-study visit in case of early termination Resulting score is regarded as QoL secondary endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None