Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Recruiting now · Not applicable
Conditions studied: Gastroesophageal Reflux Disease
In brief
The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
Key facts
- Study ID
- NCT06348420
- Run by
- Qilu Hospital of Shandong University
- People needed
- 74
- Starts
- 2024-09-10
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2024-11-18
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-60 years of age;
- Hiatal hernia ≤ 2 cm;
- Sliding hernia ≤ 2 cm;
- Recurrence of GERD symptoms after cessation of PPIs;
- On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
- Esophagitis (Los Angeles Classification) Grade B, C, or D;
- Hill's flap valve grade ≤ III;
- Observation of distal esophageal pH < 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;
- Normal or near-normal esophageal motility;
- Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;
- DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;
- Completion of a signed informed consent form.
You may not qualify if…
- BMI > 35 kg/m2;
- ASA > II;
- Barrett's esophagus;
- Hiatal hernia > 2 cm;
- Esophagitis (Los Angeles Classification) Grade A or No esophagitis；
- Hill's flap valve grade > III；
- Peptic ulcer disease;
- Primary esophageal motility disorders such as achalasia;
- Severe gastroparesis;
- History of previous esophageal or gastric surgery, including ARMS or ARMA;
- Uncontrolled systemic diseases;
- Gastric outlet obstruction;
- Pregnancy or planning to become pregnant.
Where it is running
- Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.