Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: The aim of this study is to assess the safety and effectiveness of antireflux mucosal ablation or ARAT (intervention group) in patients with chronic gastroesophageal reflux disease (GERD) symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months and objective evidence of reflux disease (positive ambulatory pH study off PPI for 5-7 days) compared to sham procedure (control group).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients with chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months and

• Objective evidence of reflux disease (positive ambulatory pH study)

• Patients prescribed standard dose of PPI for symptoms of GERD

• Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard of care checklist.

Locations
Other Locations
India
Asian Institute of Gastroenterology Hospital
RECRUITING
Hyderabad
Contact Information
Primary
Rakesh Dr Kalapala, MBBS MD DNB
drrakesh.kalapala@aighospitals.com
04023378888
Backup
Rajesh Goud Dr Maragoni, Bpharm, Mpharm, MBA, PGDM
rajeshgoud761@gmail.com
04023378888
Time Frame
Start Date: 2024-02-10
Estimated Completion Date: 2025-12-10
Participants
Target number of participants: 18
Treatments
Active_comparator: Anti reflux endoscopic theraphy using Argon plasma coagulation in GERD
To the intervention arm, the area of cardia, along greater curvature will be cleaned first followed by demarcation of a 1-1.5 cm area of non-ablation zone with two vertical lines by use of Pulsed APC using the H-APC catheter for marking and to prevent excess ablation . After this, the area of cardia, on either side will be injected in sequence using a combination of methylene blue and normal saline using the H-APC catheter jet system using between Effect 30 and Effect 70 on the ErbeJet 2 to raise the mucosa and create a submucosal cushion . Once adequate submucosal cushion is created, the mucosa starting below the z-line and up to 3 cm below will be treated by Pulsed APC 50W-80W using the H-APC catheter till golden-brown discoloration of the ablated tissue20~The area of cardia below the Z-line will be treated in a 270-320-degree fashion. Once adequate ablation is achieved and no deeper tissue injury or bleeding is ensured, the procedure will be terminated.
Placebo_comparator: Endoscopy
Patients randomized to the control arm, will undergo a sham intervention. This will include performing upper endoscopy with procedural sedation followed by markings of landmarks as described. This will be followed by gastroscope retroflexion in the gastric cardia with at least 15 minute of examination time spent in retroflexion to reciprocate the H-APC intervention. No H-APC or submucosal injection or other intervention will be performed during the upper endoscopy with sham intervention. All Patients will also continue their PPI daily for 4 weeks.
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov