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Completed

NCT Number: NCT05899491

Role of ARMA in Selective Subset of Refractory GERD Patients.

To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian institute of Gastroenterology, hyderabad, India

Hyderabad, Telangana, 500032, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARMA

Procedure

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.

UGI Endoscopy

Procedure

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 outcomes

  1. Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.

    Time frame: One Year

    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 outcomes

  1. Improvement in esophageal acid exposure

    Time frame: One Year

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

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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