--- title: Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease nct_id: NCT04711655 overall_status: COMPLETED phase: NA sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal study_type: INTERVENTIONAL primary_condition: Gastroesophageal Reflux Disease countries: Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04711655.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04711655" ct_last_update_post_date: 2025-04-24 last_seen_at: "2026-05-12T07:32:31.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease **Official Title:** Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease **NCT ID:** [NCT04711655](https://clinicaltrials.gov/study/NCT04711655) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 64 - **Lead Sponsor:** Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal - **Collaborators:** Spanish Society of Digestive Endoscopy - **Conditions:** Gastroesophageal Reflux Disease - **Start Date:** 2021-03-01 - **Completion Date:** 2025-02-07 - **CT.gov Last Update:** 2025-04-24 ## Brief Summary The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects. ## Detailed Description Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Age over 18 years. 2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation). 3. Total acid exposure time\> 6% in pH measurement study without PPI treatment. 4. Patients who do not want to take PPIs or with chronic consumption, defined as PPI consumption of more than 6 months (consecutive or not) in the last 2 years. 5. Response to PPI treatment, defined as an increase of\> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI. 6. Written informed consent to participate in the study. Exclusion Criteria: 1. Patients with sliding hiatal hernia\> 2 cm. 2. Presence of only atypical GERD symptoms. 3. Age\> 75 years. 4. Grade D peptic esophagitis. 5. Body mass index\> 35 40 kg / m2. 6. Liver cirrhosis. 7. Pregnancy. 8. Incomplete relaxation of the LES in MAR (PIR\> 15 mmHg). 9. Absent peristalsis, defined as 100% failed waves with DCI \<100 mmHg \* cm \* s in MAR. 10. Esophagogastric surgery or previous endoscopic antireflux technique. 11. Barrett's esophagus with dysplasia. 12. Oncological disease. 13. Esophageal strictures or ulcers. 14. Severe cardiopulmonary comorbidity (ASA functional class IV-V). 15. Previously known coagulopathy. 16. Severe psychiatric disorder 17. Refusal to participate in the study. ``` ## Arms - **(ARMA) antireflux ablation of the cardiac mucosa** (EXPERIMENTAL) — The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm. - **upper digestive endoscopy** (PLACEBO_COMPARATOR) — Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm. ## Interventions - **ARMA (antireflux ablation of the cardiac mucosa)** (PROCEDURE) — is an endoscopy in which argon gas ablation of the cardiac mucosa - **upper digestive endoscopy** (PROCEDURE) — Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm. ## Primary Outcomes - **To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.** _(time frame: The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).)_ — GERD-HRQL questionnaire score. Quantitative variable. Clinical success will be defined as a\> 50% reduction in symptom score. The scale has 11 items. Each item is scored from 0 to 5, with a higher score indicating a better QOL. ## Secondary Outcomes - **GERD-Q questionnaire score** _(time frame: The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).)_ - **PPI consumption** _(time frame: It is measured in the different visits after the intervention (month 1, month 3 and month 12))_ - **pHmetry-impedancemetry** _(time frame: This test will be performed on the patient before the intervention, in month 3 and in month 12)_ - **High resolution manometry** _(time frame: This test will be performed on the patient before the intervention, in month 3 and in month 12)_ ## Locations (9) - Hospital de San Agustín, Avilés, Spain - Hospital Germans Trias I Pujol, Badalona, Spain - Hospital Del Mar, Barcelona, Spain - Hospital de Cabueñes, Gijón, Spain - Hospital 12 de Octubre, Madrid, Spain - Hospital La Paz, Madrid, Spain - Complejo Hospitalario de Navarra, Pamplona, Spain - Hospital La Fe, Valencia, Spain - Hospital Rio Hortega, Valladolid, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hospital de san agustín|avilés||spain` — added _(2026-05-12)_ - `locations.hospital germans trias i pujol|badalona||spain` — added _(2026-05-12)_ - `locations.hospital del mar|barcelona||spain` — added _(2026-05-12)_ - `locations.hospital de cabueñes|gijón||spain` — added _(2026-05-12)_ - `locations.hospital 12 de octubre|madrid||spain` — added _(2026-05-12)_ - `locations.hospital la paz|madrid||spain` — added _(2026-05-12)_ - `locations.complejo hospitalario de navarra|pamplona||spain` — added _(2026-05-12)_ - `locations.hospital la fe|valencia||spain` — added _(2026-05-12)_ - `locations.hospital rio hortega|valladolid||spain` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04711655.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04711655* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*