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ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) (ARMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243668
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Rakesh K, Asian Institute of Gastroenterology, India

Brief 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 pilot study Sample size: 20


Condition or disease Intervention/treatment Phase
GERD Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE:PROSPECTIVE INTERVENTIONAL PILOT STUDY
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : September 2, 2020
Estimated Study Completion Date : September 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: ANTI REFLUX MUCOSAL ABLATION THERAPHY
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.
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.





Primary Outcome Measures :
  1. Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months [ Time Frame: 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


Secondary Outcome Measures :
  1. requirement of PPI at 3, 6 and 12 months [ Time Frame: 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

  2. Improvement in esophageal acid exposure [ Time Frame: 6 months ]
    Improvement in esophageal acid exposure in PH impedence monitoring report from baseline

  3. Improvement in lower esophageal sphincter pressure at 3 months [ Time Frame: 12 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243668


Contacts
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Contact: Rakesh Kalapala, DNB 9989211034 drkalpala@gmail.com
Contact: Arun Karyumpudi, DNB 9695169962 drarunkp87@gmail.com

Locations
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India
Asian Institute of Gastroenterology Recruiting
Hyderabad, Telangana, India, 500082
Contact: Rakesh Kalapala, DNB    9989211034    drkalapala@gmail.com   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Study Director: Nageshwar Reddy, DNB Chairman
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Responsible Party: Rakesh K, PRINCIPAL INVESTIGATOR, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT04243668    
Other Study ID Numbers: ARMA01
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No