Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641375
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation AREA in Gastroesophageal Reflux Disease GERD Patients A Single Center Randomized Sham Controlled Trial The AREA Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation AREA in Gastroesophageal Reflux Disease GERD Patients
Status:
RECRUITING
Status Verified Date:
2024-10
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:
AREA
Brief Summary:
Background and Rationale
Gastroesophageal reflux disease is affecting 1 in 3 US adults with half experiencing daily symptoms Per recent data more than 50 continue to experience daily symptoms despite taking medical therapy and not eligible for surgery In that small fraction of patients who are eligible for surgery more than 70 resume taking a medicine for their reflux disease GERD is common among the US veterans and currently there is a lack of minimally invasive endoscopic therapies for management of GERD This study will investigate performance of minimally invasive endoscopic therapy using antireflux mucosal ablation hybrid argon plasma coagulation that has been used in other areas of GI tract with efficacy and safety for management of chronic GERD among the US veterans
Objective
The aim of this study is to assess the safety and effectiveness of antireflux mucosal ablation or ARAT intervention group in patients with chronic gastroesophageal reflux disease GERD symptoms typical symptoms of GERD ie heartburn or acid refluxregurgitation at least twice a week for the last 6 months and objective evidence of reflux disease positive ambulatory pH study off PPI for 5-7 days compared to sham procedure control group
Gastroesophageal reflux disease is affecting 1 in 3 US adults with half experiencing daily symptoms Per recent data more than 50 continue to experience daily symptoms despite taking medical therapy and not eligible for surgery In that small fraction of patients who are eligible for surgery more than 70 resume taking a medicine for their reflux disease GERD is common among the US veterans and currently there is a lack of minimally invasive endoscopic therapies for management of GERD This study will investigate performance of minimally invasive endoscopic therapy using antireflux mucosal ablation hybrid argon plasma coagulation that has been used in other areas of GI tract with efficacy and safety for management of chronic GERD among the US veterans
Objective
The aim of this study is to assess the safety and effectiveness of antireflux mucosal ablation or ARAT intervention group in patients with chronic gastroesophageal reflux disease GERD symptoms typical symptoms of GERD ie heartburn or acid refluxregurgitation at least twice a week for the last 6 months and objective evidence of reflux disease positive ambulatory pH study off PPI for 5-7 days compared to sham procedure control group
Detailed Description:
InclusionExclusion criteria Inclusion
Patients with chronic GERD symptoms at least 1 typical symptom of GERD ie heartburn or acid refluxregurgitation at least twice a week for last 6 months and
Objective evidence of reflux disease positive ambulatory pH study
Patients prescribed standard dose of PPI for symptoms of GERD
Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist
Exclusion
1 Patients unable to or unwilling to participate or consent
2 Age 18 years or 80 years
3 Allergic or intolerant to PPI medications
4 Large hiatal hernia 3 cm and Hill grade IV
5 Barretts esophagus
6 Esophageal stricture with any prior intervention
7 Major motility disorder on HRM
7 Eosinophilic esophagitis 8 Gastroparesis documented by abnormal gastric emptying time 9 Previous fundoplication myotomy or LINX surgery 10 Cirrhosis with esophageal andor gastric varices
Study groups
Patients recruited will be randomized to undergo antireflux mucosal ablation ARAT OR sham intervention after inclusion and exclusion criteria have been met
Study procedure
Patients will be randomized 11 to one of the arms by computer generated random sequence of numbers
The following study visits are foreseen for each patient
Screening Visits A screening visit is performed at the investigational site During this visit out-patients will be informed about the aims procedures benefits and possible risks of the study prior to signing the informed consent form for inclusion in the study Their medical history will be recorded as well as eventual clinical or laboratory examinations according to the local standard of care preparation for an upper endoscopy
Randomization Intervention visit Each eligible patient returns to the clinic to undergo either the study intervention OR sham intervention
24-48 hour and 7-10 day post randomization phone call for adverse events among both groups
25-30 day post randomization phone call for adverse events among both groups
3-4 Month 80-112 days post randomization visit with upper endoscopy and ambulatory pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
6-7 month 165-196 days post randomization visit phone call to include administration of the validated GERD-HRQL and RDQ questionnaires
11-12 month 336-365 days post randomization visit with upper endoscopy and ambulatory pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
1 To determine if ARAT can improve GERD-HRQL score 50 compared to sham intervention at 3 6 and 12 months
2 To determine if ARAT can decrease GERD scores RDQ 50 compared to sham intervention at 3 6 and 12 months
Secondary aims
1 To determine if ARAT can reduce esophageal acid exposure time 4 using wireless ambulatory 24-hr pH monitoring in 50 subjects compared to sham intervention at 3 and 12 months
2 To determine if ARAT can achieve 50 reduction in DeMeester score compared to sham intervention at 3 and 12 months
3 To determine if ARAT can achieve PPI dose reduction or discontinuation in 25 of subjects after 3 months compared to sham intervention
4 To evaluate the safety profile of ARAT the rapy by recording major GI bleeding perforation hospitalization esophageal stricture and minor complications chest pain fever dysphagia 75 Follow up Following the baseline assessment and performance of the upper endoscopy either true intervention or sham patients in both groups will be asked to complete the GERD-HRQL and RDQ questionnaires at 3 month 6 month and 12 months using appropriate case report forms In addition the study staff will contact the patients by phone call at day 24- 48 hours by phone call at 7-10 days and 25-30 days post procedure to record any adverse events This will be accomplished using designated case report forms At months 3 and 12 all patients will also undergo an upper endoscopy with assessment for
erosive esophagitis and placement of pH capsule During the 3 month 6 month and 12 months visit use of PPI therapy dose and frequency will be recorded Response to therapy will be assessed using the following parameters improvement of GERD-HRQL scores reduction in RDQ scores AET 4 and DeMeester score 14 off PPI Any patients with dysphagia after the ARAT will undergo repeat endoscopy for evaluation If significant stricture endoscopic dilation will be performed per severity of symptoms and stenosis
Duration of this study from subject randomization to completion is 1 year however we anticipate study duration of at least 24 months for subject screening completion of study visits and data analysis
Patients with chronic GERD symptoms at least 1 typical symptom of GERD ie heartburn or acid refluxregurgitation at least twice a week for last 6 months and
Objective evidence of reflux disease positive ambulatory pH study
Patients prescribed standard dose of PPI for symptoms of GERD
Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist
Exclusion
1 Patients unable to or unwilling to participate or consent
2 Age 18 years or 80 years
3 Allergic or intolerant to PPI medications
4 Large hiatal hernia 3 cm and Hill grade IV
5 Barretts esophagus
6 Esophageal stricture with any prior intervention
7 Major motility disorder on HRM
7 Eosinophilic esophagitis 8 Gastroparesis documented by abnormal gastric emptying time 9 Previous fundoplication myotomy or LINX surgery 10 Cirrhosis with esophageal andor gastric varices
Study groups
Patients recruited will be randomized to undergo antireflux mucosal ablation ARAT OR sham intervention after inclusion and exclusion criteria have been met
Study procedure
Patients will be randomized 11 to one of the arms by computer generated random sequence of numbers
The following study visits are foreseen for each patient
Screening Visits A screening visit is performed at the investigational site During this visit out-patients will be informed about the aims procedures benefits and possible risks of the study prior to signing the informed consent form for inclusion in the study Their medical history will be recorded as well as eventual clinical or laboratory examinations according to the local standard of care preparation for an upper endoscopy
Randomization Intervention visit Each eligible patient returns to the clinic to undergo either the study intervention OR sham intervention
24-48 hour and 7-10 day post randomization phone call for adverse events among both groups
25-30 day post randomization phone call for adverse events among both groups
3-4 Month 80-112 days post randomization visit with upper endoscopy and ambulatory pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
6-7 month 165-196 days post randomization visit phone call to include administration of the validated GERD-HRQL and RDQ questionnaires
11-12 month 336-365 days post randomization visit with upper endoscopy and ambulatory pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
1 To determine if ARAT can improve GERD-HRQL score 50 compared to sham intervention at 3 6 and 12 months
2 To determine if ARAT can decrease GERD scores RDQ 50 compared to sham intervention at 3 6 and 12 months
Secondary aims
1 To determine if ARAT can reduce esophageal acid exposure time 4 using wireless ambulatory 24-hr pH monitoring in 50 subjects compared to sham intervention at 3 and 12 months
2 To determine if ARAT can achieve 50 reduction in DeMeester score compared to sham intervention at 3 and 12 months
3 To determine if ARAT can achieve PPI dose reduction or discontinuation in 25 of subjects after 3 months compared to sham intervention
4 To evaluate the safety profile of ARAT the rapy by recording major GI bleeding perforation hospitalization esophageal stricture and minor complications chest pain fever dysphagia 75 Follow up Following the baseline assessment and performance of the upper endoscopy either true intervention or sham patients in both groups will be asked to complete the GERD-HRQL and RDQ questionnaires at 3 month 6 month and 12 months using appropriate case report forms In addition the study staff will contact the patients by phone call at day 24- 48 hours by phone call at 7-10 days and 25-30 days post procedure to record any adverse events This will be accomplished using designated case report forms At months 3 and 12 all patients will also undergo an upper endoscopy with assessment for
erosive esophagitis and placement of pH capsule During the 3 month 6 month and 12 months visit use of PPI therapy dose and frequency will be recorded Response to therapy will be assessed using the following parameters improvement of GERD-HRQL scores reduction in RDQ scores AET 4 and DeMeester score 14 off PPI Any patients with dysphagia after the ARAT will undergo repeat endoscopy for evaluation If significant stricture endoscopic dilation will be performed per severity of symptoms and stenosis
Duration of this study from subject randomization to completion is 1 year however we anticipate study duration of at least 24 months for subject screening completion of study visits and data analysis
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