Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease

Last updated: April 22, 2025
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Overall Status: Completed

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

upper digestive endoscopy

ARMA (antireflux ablation of the cardiac mucosa)

Clinical Study ID

NCT04711655
ECA-HRC-ARMA
  • Ages 18-75
  • All Genders

Study Summary

The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age over 18 years.

  2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They shouldat 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 PPIconsumption 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-HRQLquestionnaire 15 days after discontinuation of the PPI.

  6. Written informed consent to participate in the study.

Exclusion

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.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: upper digestive endoscopy
Phase:
Study Start date:
March 01, 2021
Estimated Completion Date:
February 07, 2025

Study 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.

Connect with a study center

  • Hospital de San Agustín

    Avilés,
    Spain

    Site Not Available

  • Hospital Germans Trias I Pujol

    Badalona,
    Spain

    Site Not Available

  • Hospital Del Mar

    Barcelona,
    Spain

    Site Not Available

  • Hospital de Cabueñes

    Gijón,
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital La Paz

    Madrid,
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Hospital de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Hospital La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital Rio Hortega

    Valladolid,
    Spain

    Site Not Available

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