ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

GERD Clinical Trial

— ARMA  

Official title:

ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE: OPEN LABEL SINGLE CENTER OBSERVATIONAL STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243668
• Other study ID #: ARMA01
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD) DESIGN OF THE Prospective interventional study Sample size: 216

Description:

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0 Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire. Inclusion criteria - Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI - Patients who are willing to pay the expenses of the ARMA procedure Exclusion criteria - Large Hiatal hernia >3cm - Gr C/D esophagitis - Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg - Paraesophageal hernia - GE flap valve grade IV (Hill's classification) - Barretts esophagus - Esophageal dysmotility - ASA physical status >II - Previous esophageal or gastric surgery - Pregnancy Patients screening and inclusion: The study will be conducted over 6-months period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD HRQL and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal LES pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed.Those patients with pathologic esophageal acid exposure as described previously will be included in the trial. Patients will then be directly assigned by a computer to ARMA procedure. The principle investigator and the study coordinators would be open label to the treatment assignment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 30, 2023
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• • Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
• Patients who are willing to pay the expenses of the ARMA procedure

Exclusion Criteria:

• • Large Hiatal hernia >3cm
• Gr C/D esophagitis
• Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
• Paraesophageal hernia
• GE flap valve grade IV (Hill's classification)
• Barretts esophagus
• Esophageal dysmotility
• ASA physical status >II
• Previous esophageal or gastric surgery
• Pregnancy

Related Conditions & MeSH terms

• GERD

Intervention

Procedure:
• ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months	Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE	3 months
Secondary	requirement of PPI at 3, 6 and 12 months	requirement of Proton Pump Inhibitors at 3, 6 and 12 months based on GERD score evaluated based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE	requirement of PPI at 3, 6 and 12 months
Secondary	Improvement in esophageal acid exposure	Improvement in esophageal acid exposure in PH impedence monitoring report from baseline	6 months
Secondary	Improvement in lower esophageal sphincter pressure at 3 months	Improvement in lower esophageal sphincter pressure at 3 months i.e sphincter pressure will be less compare to baseline pressure which will be known by the Esophageal manometry report.	12 months