Clinical trial NCT05570448: Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)
Official 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro Esophageal Reflux
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months.

Patients must have a positive pH test and a negative manometry (no treatment) procedure.


Eligibility criteria: Inclusion Criteria:

* Chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months
* Objective evidence of reflux disease (positive ambulatory pH study.)

Exclusion Criteria:

* Patients unable to or unwilling to participate or consent.
* Age \<18 years or \>80 years.
* Allergic or intolerant to PPI medications.
* Large hiatal hernia \> 3 cm and Hill grade IV.
* Barrett's esophagus.
* Esophageal stricture with any prior intervention.
* Major motility disorder.
* Eosinophilic esophagitis.
* Gastroparesis documented by abnormal gastric emptying time.
* Previous fundoplication, myotomy or LINX surgery.
* Cirrhosis with esophageal and/or gastric varices.

Primary outcomes:
measure: Change in GERD health related quality of life (GERD-HRQL) score
timeFrame: At 3, 6 and 12 months
Secondary outcomes:
measure: Change in Reflux disease questionnaire (RDQ) score
timeFrame: At 3, 6 and 12 months
measure: Change in Proton pump inhibitor (PPI) use
timeFrame: At 3, 6 and 12 months
measure: Acid exposure time (AET)
timeFrame: At 3 and 12 months
measure: Adverse events
timeFrame: Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)
measure: Change in Hiatal hernia grading
timeFrame: At 3 and 12 months
measure: Esophagitis incidence
timeFrame: At 3 and 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City VA Hospital
state: Missouri
Study officials:
affiliation: Kansas City VA Hospital
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansas City VA Hospital
name: Madhav Desai, MD
role: STUDY_DIRECTOR
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