Asian institute of Gastroenterology, hyderabad, India
Hyderabad, Telangana, 500032, India
NCT Number: NCT05899491
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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Notify Me19 year and older
All sexes
Interventional
Not applicable
Hyderabad, Telangana, 500032, India
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
Time frame: One Year
Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.
Asian Institute of Gastroenterology, India
Other
Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.
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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