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Gastroesophageal Reflux DiseaseNCT04711655

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

A study testing ARMA (antireflux ablation of the cardiac mucosa) and upper digestive endoscopy in people with Gastroesophageal Reflux Disease, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
ARMA (antireflux ablation of the cardiac mucosa) and upper digestive endoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
9 sitesSpain
Study dates
1 Mar 2021to 7 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years.
  • GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation).
  • Total acid exposure time> 6% in pH measurement study without PPI treatment.
  • 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.
  • Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI.
  • Written informed consent to participate in the study.

Who cannot join

  • Patients with sliding hiatal hernia> 2 cm.
  • Presence of only atypical GERD symptoms.
  • Age> 75 years.
  • Grade D peptic esophagitis.
  • Body mass index> 35 40 kg / m2.
  • Liver cirrhosis.
Show all 17Show fewer
  • Pregnancy.
  • Incomplete relaxation of the LES in MAR (PIR> 15 mmHg).
  • Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR.
  • Esophagogastric surgery or previous endoscopic antireflux technique.
  • Barrett's esophagus with dysplasia.
  • Oncological disease.
  • Esophageal strictures or ulcers.
  • Severe cardiopulmonary comorbidity (ASA functional class IV-V).
  • Previously known coagulopathy.
  • Severe psychiatric disorder
  • Refusal to participate in the study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Hospital de San Agustín

    Avilés

  • Hospital Germans Trias I Pujol

    Badalona

  • Hospital Del Mar

    Barcelona

  • Hospital de Cabueñes

    Gijón

  • Hospital 12 de Octubre

    Madrid

  • Hospital La Paz

    Madrid

  • Complejo Hospitalario de Navarra

    Pamplona

  • Hospital La Fe

    Valencia

  • Hospital Rio Hortega

    Valladolid

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
ARMA (antireflux ablation of the cardiac mucosa), upper digestive endoscopy
Keywords
endoscopy, argon gas, antireflux ablation of the cardiac mucosa (ARMA)
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARMA (antireflux ablation of the cardiac mucosa)Procedure or surgery

    is an endoscopy in which argon gas ablation of the cardiac mucosa

  • upper digestive endoscopyProcedure or surgery

    Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.

Study groups in NCT04711655
Study groupRoleWhat they receive
(ARMA) antireflux ablation of the cardiac mucosaExperimentalThe ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm.
Receives: Procedure: ARMA (antireflux ablation of the cardiac mucosa)
upper digestive endoscopyPlacebo comparatorQuality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.
Receives: Procedure: upper digestive endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.

    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.

    Measured: The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).

Secondary outcomes (4)

  1. GERD-Q questionnaire score

    The GERDQ questionnaire is diagnostic for gastroesophageal reflux disease. Clinical success will be defined as a> 50% reduction in symptom score. The total Total score of 0 to 2 points = 0 % likelihood of GERD; 3 to 7 points = 50 %; 8 to 10 points = 79 %; 1 to 18 points = 89%;

    Measured: The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).

  2. PPI consumption

    Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied.

    Measured: It is measured in the different visits after the intervention (month 1, month 3 and month 12)

  3. pHmetry-impedancemetry

    Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is acid exposure time.

    Measured: This test will be performed on the patient before the intervention, in month 3 and in month 12

  4. High resolution manometry

    This technique measures the pressure of esophageal contractions and with this technique different measurements are obtained such as lower esophageal sphincter resting pressure, integrated relaxation pressure, ICD.

    Measured: This test will be performed on the patient before the intervention, in month 3 and in month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2023
  4. Study completion7 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04711655
Sponsor's protocol ID
ECA-HRC-ARMA
Status last verified
Jul 2024
First submitted
21 Dec 2020
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rodriguez de Santiago E, Teruel Sanchez-Vegazo C, Albeniz E, Estremera Arevalo F, Arrubla Gamboa A, Castel I, Arribas Anta J, Marin-Gabriel JC, Diez Redondo P, Nunez Rodriguez H, Herreros De Tejada A, El Hajra Martinez I, Riu Pons F, Naves JE, Uchima H, Marin I, Duque Alcorta JM, Perez Corte D, De Maria Pallares P, Perez Enciso I, Garcia Suarez C, Lorenzo-Zuniga V, Nogales O, Muriel A, Albillos A; ECA-ARMA authors of the Mucosal Resection and Third-Space Endoscopy SEED Working Group. Multicenter, double-blind, sham endoscopy-controlled, randomized trial evaluating the efficacy of antireflux mucosal ablation for the treatment of gastroesophageal reflux disease. Endoscopy. 2026 Jun;58(6):595-607. doi: 10.1055/a-2780-0706. Epub 2025 Dec 31.

    PubMed 41475422

Questions about this trial

What is this clinical trial studying?

A study testing ARMA (antireflux ablation of the cardiac mucosa) and upper digestive endoscopy in people with Gastroesophageal Reflux Disease, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04711655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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