Actively Recruiting
Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Led by Qilu Hospital of Shandong University · Updated on 2024-11-18
74
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
S
Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Hiatal hernia 2 cm or smaller
- Sliding hernia 2 cm or smaller
- Recurrence of GERD symptoms after stopping PPIs
- Taking daily PPIs for 1 year or twice daily PPIs for at least 8 weeks
- Esophagitis Grade B, C, or D (Los Angeles Classification)
- Hill's flap valve grade 3 or less
- Distal esophageal pH less than 4 on 1-2 days in a 7-day period, exceeding 5.3%
- Normal or near-normal esophageal movement
- Lower esophageal sphincter pressure between 5 and 15 mmHg
- DeMeester score 14.7 or higher or total reflux episodes over 73
- Signed informed consent form
You will not qualify if you...
- Body Mass Index over 35 kg/m2
- ASA physical status classification greater than II
- Barrett's esophagus
- Hiatal hernia larger than 2 cm
- Esophagitis Grade A or no esophagitis
- Hill's flap valve grade higher than 3
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
J
jiaoyang j lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here