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NCT Number: NCT05570448

Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansas City VA Hospital

Kansas City, Missouri, 64128, United States

Location status: Recruiting

Location contact

Abhilash Perisetti, MD

SUB_INVESTIGATOR

April Higbee, BSN

CONTACT

[email protected]

816-861-4700

Carlissa Campbell, MA

CONTACT

[email protected]

816-861-4700

Madhav Desai, MD

SUB_INVESTIGATOR

Prateek Sharma, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patients unable to or unwilling to participate or consent.
  • Age <18 years or >80 years.
  • Allergic or intolerant to PPI medications.
  • Large hiatal hernia > 3 cm and Hill grade IV.
  • Barrett's esophagus.
  • Esophageal stricture with any prior intervention.
  • Major motility disorder.
  • Eosinophilic esophagitis.
  • Gastroparesis documented by abnormal gastric emptying time.
  • Previous fundoplication, myotomy or LINX surgery.
  • Cirrhosis with esophageal and/or gastric varices.

Treatment and study plan

ARAT

Procedure

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.

Other names: Anti-reflux mucosal ablation

Sham intervention (control)

Procedure

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.

Primary outcomes

  1. Change in GERD health related quality of life (GERD-HRQL) score

    Time frame: At 3, 6 and 12 months

    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.

Secondary outcomes

  1. Change in Reflux disease questionnaire (RDQ) score

    Time frame: At 3, 6 and 12 months

    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.

  2. Change in Proton pump inhibitor (PPI) use

    Time frame: At 3, 6 and 12 months

    Frequency of PPI medication use

  3. Acid exposure time (AET)

    Time frame: At 3 and 12 months

    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.

  4. Adverse events

    Time frame: Post-randomization (Day 1, Day 30, 3rd, 6th and 12th month)

    Frequency of any adverse event including chest pain, bleeding, dysphagia, hospitalization

  5. Change in Hiatal hernia grading

    Time frame: At 3 and 12 months

    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.

  6. Esophagitis incidence

    Time frame: At 3 and 12 months

    LA grade esophagitis at the time of endoscopy

Study contacts

Contact information is provided by the study sponsor or research team.

April Higbee, BSN

CONTACT

[email protected]

816-861-4700

Carlissa Campbell, MS

CONTACT

[email protected]

816-861-4700

Sponsors and collaborators

Lead sponsor

Midwest Veterans' Biomedical Research Foundation

Other

Registry information

Official study title

Anti-Reflux Endoscopic Therapy Using Argon Plasma Coagulation (AREA) in Gastroesophageal Reflux Disease (GERD) Patients: A Single Center, Randomized, Sham, Controlled Trial (The AREA Study)

Acronym: AREA21

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2022
Registry last updated
Feb 27, 2026

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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