Status:
COMPLETED
Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Spanish Society of Digestive Endoscopy
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04711655
Start Date
March 1 2021
End Date
February 7 2025
Last Update
April 24 2025
Active Locations (9)
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1
Hospital de San Agustín
Avilés, Spain
2
Hospital Germans Trias I Pujol
Badalona, Spain
3
Hospital Del Mar
Barcelona, Spain
4
Hospital de Cabueñes
Gijón, Spain