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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05570448
Other study ID # PS0100
Secondary ID 1650419
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date April 2025

Study information

Verified date October 2022
Source Midwest Veterans' Biomedical Research Foundation
Contact April Higbee, BSN
Phone 816-861-4700
Email april.higbee@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months. Patients must have a positive pH test and a negative manometry (no treatment) procedure.


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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ARAT
For patients randomized to ARAT intervention, the area of cardia, along greater curvature will be cleaned followed by demarcation of a 1-1.5 cm area of non-ablation zone with two vertical lines by use of Pulsed APC (30W, Effect 2) using the H-APC catheter. Next, the area of cardia, on either side will be injected in sequence using a methylene blue (0.5%) and normal saline (0.9%) using the H-APC catheter jet system (Effect 30-70). Next, the mucosa, starting below the z-line and up to 3 cm below will be treated by Pulsed APC 50W-80W till golden-brown discoloration of the ablated tissue in 270-320 degree. For patients randomized to control or sham intervention, upper endoscopy with procedural sedation was performed followed by markings of landmarks followed by gastroscope retroflexion in the gastric cardia with at least 15 minute of examination time. No H-APC or submucosal injection or other intervention will be performed.
Sham intervention (control)
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.

Locations

Country Name City State
United States Kansas City VA Hospital Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Midwest Veterans' Biomedical Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in GERD health related quality of life (GERD-HRQL) score The primary outcome of quality of life will be measured using the validated GERD related quality of life questionnaire (GERD-HRQL). The total score is 50, and a higher score is associated with more severe symptoms. At 3, 6 and 12 months
Secondary Change in Reflux disease questionnaire (RDQ) score RDQ scores will be assessed using a validated questionnaire scale. The total score is 40, and a higher score is associated with more severe symptoms. At 3, 6 and 12 months
Secondary Change in Proton pump inhibitor (PPI) use Frequency of PPI medication use At 3, 6 and 12 months
Secondary Acid exposure time (AET) Ambulatory acid reflux testing (wireless pH monitoring system) for measurement. Acid exposure time measures amount of time spent in pH <4. A time >4% is considered positive for acid reflux. At 3 and 12 months
Secondary Adverse events Frequency of any adverse event including chest pain, bleeding, dysphagia, hospitalization Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)
Secondary Change in Hiatal hernia grading Hill grade for hiatal hernia assessment during endoscopy. There are 4 grades: I, II, III and IV depending on the appearance of the hiatus on endoscopy. At 3 and 12 months
Secondary Esophagitis incidence LA grade esophagitis at the time of endoscopy At 3 and 12 months
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