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New treatment option for GERD
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)
ClinicalTrials.gov ID: NCT06641375
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last...
- 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.
You likely can't join if
- Patients unable to or unwilling to participate or consent
- Age \ 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
See the full eligibility criteria
- Patients with 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 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.
- Patients unable to or unwilling to participate or consent
- Age \ 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 on HRM 7\. Eosinophilic esophagitis 8. Gastroparesis documented by abnormal gastric emptying time 9. Previous fundoplication, myotomy or LINX surgery 10. Cirrhosis with esophageal and/or gastric...
The study team makes the final eligibility decision.
Where it's taking place
- Hyderabad, Telangana, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderabad, Telangana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.