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ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) (ARMA)

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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

Tracking Information
First Submitted Date  ICMJE January 7, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE September 2, 2019
Estimated Primary Completion Date September 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • 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
  • Improvement in esophageal acid exposure [ Time Frame: 6 months ]
    Improvement in esophageal acid exposure in PH impedence monitoring report from baseline
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
Official Title  ICMJE ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE:PROSPECTIVE INTERVENTIONAL PILOT STUDY
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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE GERD
Intervention  ICMJE 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.

Study Arms  ICMJE 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.
Intervention: Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2020)
20
Estimated Study Completion Date  ICMJE September 2, 2020
Estimated Primary Completion Date September 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rakesh Kalapala, DNB 9989211034 drkalpala@gmail.com
Contact: Arun Karyumpudi, DNB 9695169962 drarunkp87@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243668
Other Study ID Numbers  ICMJE ARMA01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rakesh K, Asian Institute of Gastroenterology, India
Study Sponsor  ICMJE Asian Institute of Gastroenterology, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nageshwar Reddy, DNB Chairman
PRS Account Asian Institute of Gastroenterology, India
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP