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Role of ARMA in Selective Subset of Refractory GERD Patients.

Primary Purpose

GERD, Reflux, Reflux Esophagitis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ARMA
UGI Endoscopy
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Normal Upper Gastrointestinal endoscopy And 24 hour pH Impedance: AET < 6%, More than 80 refluxes Patients who are willing to give consent for the procedure Exclusion Criteria: Large Hiatal hernia >3cm Lower esophageal sphincter (LES) pressure >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

Sites / Locations

  • Asian institute of Gastroenterology, hyderabad, IndiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ARMA Group

Sham Group

Arm Description

All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.

UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvement in esophageal acid exposure
Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.

Full Information

First Posted
April 1, 2023
Last Updated
June 2, 2023
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT05899491
Brief Title
Role of ARMA in Selective Subset of Refractory GERD Patients.
Official Title
Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).
Detailed Description
Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) & Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus. Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease. 24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters. All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD, Reflux, Reflux Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A Randomized Sham Control Trial
Masking
None (Open Label)
Masking Description
A Randomized Sham Control Trial
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARMA Group
Arm Type
Active Comparator
Arm Description
All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
ARMA
Intervention Description
Patients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.
Intervention Type
Procedure
Intervention Name(s)
UGI Endoscopy
Intervention Description
UGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire.
Primary Outcome Measure Information:
Title
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Improvement in esophageal acid exposure
Description
Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal Upper Gastrointestinal endoscopy And 24 hour pH Impedance: AET < 6%, More than 80 refluxes Patients who are willing to give consent for the procedure Exclusion Criteria: Large Hiatal hernia >3cm Lower esophageal sphincter (LES) pressure >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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeraj Singla, MD, DM
Phone
8669188042
Ext
+91
Email
docneersk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeraj Singla, MD
Organizational Affiliation
Asian Institute of Gastroenterology, Hyderabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Digvijay Chavan
Organizational Affiliation
Asian Institute of Gastroenterology, Hyderabad
Official's Role
Study Chair
Facility Information:
Facility Name
Asian institute of Gastroenterology, hyderabad, India
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500032
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Singla
Phone
07013454913
Email
docneersk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32010745
Citation
Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.
Results Reference
result
PubMed Identifier
36109362
Citation
Chou CK, Chen CC, Chen CC, Wu JF, Liao WC, Chiu HM, Wang HP, Wu MS, Tseng PH. Positive and negative impact of anti-reflux mucosal intervention on gastroesophageal reflux disease. Surg Endosc. 2023 Feb;37(2):1060-1069. doi: 10.1007/s00464-022-09605-z. Epub 2022 Sep 15.
Results Reference
result
PubMed Identifier
34754155
Citation
Rodriguez de Santiago E, Albeniz E, Estremera-Arevalo F, Teruel Sanchez-Vegazo C, Lorenzo-Zuniga V. Endoscopic anti-reflux therapy for gastroesophageal reflux disease. World J Gastroenterol. 2021 Oct 21;27(39):6601-6614. doi: 10.3748/wjg.v27.i39.6601.
Results Reference
result

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Role of ARMA in Selective Subset of Refractory GERD Patients.

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