Trial comparing treatments for Gastroesophageal Reflux Disease
Official title Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
ClinicalTrials.gov ID: NCT06348420
What this study is testing
- What it's testing
- The study objective is to look at the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
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 60
You may be able to join 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;
You likely can't join 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；
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Jinan, Shandong, China
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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jinan, Shandong, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.