NCT06348420 Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
| NCT ID | NCT06348420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Gastroesophageal Reflux Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2024-09-10 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06348420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Gastroesophageal Reflux Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06348420 currently recruiting?
Yes, NCT06348420 is actively recruiting participants. Contact the research team at lujiaoyang@sdu.edu.cn for enrollment information.
Where is the NCT06348420 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06348420 clinical trial?
NCT06348420 is sponsored by Qilu Hospital of Shandong University. The trial plans to enroll 74 participants.