None listed
Conditions
Interventions
Medical Device : Enrolled subjects will be randomly assigned in a 1:1 ratio to either the sham control group or the EsoLight Z360 treatment group after hospitalization (Visit 2). The following day (Vi
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged =20 and <80 years at the time of enrollment. 2. Patients with gastroesophageal reflux disease (GERD) dependent on proton pump inhibitors (PPIs). • PPI-dependent GERD refers to cases where symptoms are effectively managed with medication but relapse upon discontinuation, requiring continuous PPI use for more than 8 weeks. • GERD is defined as having typical esophageal symptoms such as reflux or heartburn, occurring mildly on =2 days per week or moderately to severely on =1 day per week. Even in patients presenting with typical GERD symptoms, more than 60% may show non-erosive reflux disease (NERD) on endoscopy. Additionally, patients presenting with atypical extra-esophageal symptoms (e.g., cough, globus sensation, chest pain) may still be diagnosed with GERD if endoscopy reveals erosive esophagitis classified as LA grade B, C, or D. 3. GerdQ score of 8 or higher at the time of screening. 4. Individuals who voluntarily provide written informed consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Presence of any of the following esophageal conditions: • Esophageal stricture, esophageal diverticulum, or Barrett’s esophagus =3 cm • Hiatal hernia >2 cm in size • Presence of gastroesophageal varices • Active gastrointestinal bleeding 2. Abnormal findings on esophageal manometry: • Median integrated relaxation pressure (IRP) exceeding the normal range in either supine or upright position as measured by high-resolution esophageal manometry (HREM) using the Chicago Classification version 4.0* • Any esophageal motility disorder other than ineffective esophageal motility (IEM)** • Esophageal manometry is conducted using high-resolution esophageal manometry in accordance with the Chicago Classification v4.0, measuring 10 swallows in supine and 5 in upright positions. Normal ranges: Medtronic – supine IRP 5 cm transition zone). *** Medtronic sensors are located internally within the catheter, whereas Diversatek/Laborie sensors are external. These structural differences account for variation in normal ranges. The Chicago Classification acknowledges such variations in measurement thresholds based on system type. [21] 3. History of anti-reflux surgery or other surgical interventions involving the stomach or esophagus 4. Body mass index (BMI) = 35 5. Individuals who require additional medications related to GERD beyond the rescue medication (esomeprazole) provided in the study 6. History of hypersensitivity or lack of response to esomeprazole 7. History within the past 3 months (prior to Visit 1) of any of the following: • Thrombotic events (e.g., cerebral thrombosis, myocardial infarction, thrombophlebitis) or coagulation disorders [18] 8. Inability to discontinue antithrombotic agents for the required duration [18]: • Antiplatelet agents: 1 week • Warfarin: 5 days • DOACs: 2 days • Other supplements: 1 week 9. Presence of implanted electronic medical devices such as a cardiac pacemaker [18] 10. Positive pregnancy test, current pregnancy, breastfeeding, or women of childbearing potential not using adequate contraception* • Adequate contraception includes: condoms, oral contraceptives, injectable or implantable contraceptives, intrauterine devices (IUD), tubal ligation, or surgical sterilization 11. History within 30 days prior to Visit 1 of drug abuse, alcohol dependence, or clinically significant psychiatric illness [22] 12. Individuals with any of the following contraindications: - Not suitable for surgery under general conditions - Contraindication to laser therapy - Pediatric patients - Contraindication to anesthesia required for the procedure - Inability or refusal to undergo endoscopic procedure - Presence of tissue calcification (especially tumors) 13. Any other condition deemed by the investigator to make the participant unsuitable for the study (e.g., AIDS, active hepatitis, excessive smoking or alcohol use)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in GerdQ Score from Baseline Between the Sham Control Group and the EsoLight Z360 Treatment Group | — |
Secondary
| Measure | Time frame |
|---|---|
| Change Rate of Esophageal Pressure from Baseline Between the Sham Control Group and the EsoLight Z360 Treatment Group;24-hour Ambulatory Esophageal pH Monitoring Parameters Compared to Baseline in the Sham Control Group and the EsoLight Z360 Treatment Group;Change in RSI Score from Baseline in the Sham Control Group and the EsoLight Z360 Treatment Group;Esomeprazole Dosage Over 12 and 24 Weeks in the Sham Control Group and the EsoLight Z360 Treatment Group;Change in GerdQ Score from Baseline in the Sham Control Group and the EsoLight Z360 Treatment Group;Adverse Events Identified Through Blood Tests and Chest X-rays in the Sham Control Group and the EsoLight Z360 Treatment Group | — |
Countries
Korea, Republic of
Contacts
Public ContactDo Hoon Kim
Asan Medical Center
Outcome results
None listed