RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2022-02-15
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05570448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Objective evidence of reflux disease (positive ambulatory pH study.)
  1. * Patients unable to or unwilling to participate or consent.
  2. * Age \<18 years or \>80 years.
  3. * Allergic or intolerant to PPI medications.
  4. * Large hiatal hernia \> 3 cm and Hill grade IV.
  5. * Barrett's esophagus.
  6. * Esophageal stricture with any prior intervention.
  7. * Major motility disorder.
  8. * Eosinophilic esophagitis.
  9. * Gastroparesis documented by abnormal gastric emptying time.
  10. * Previous fundoplication, myotomy or LINX surgery.
  11. * Cirrhosis with esophageal and/or gastric varices.

Contacts and Locations

Study Contact

April Higbee, BSN
CONTACT
816-861-4700
april.higbee@va.gov
Carlissa Campbell, MS
CONTACT
816-861-4700
Carlissa.Campbell@va.gov

Principal Investigator

Prateek Sharma, MD
PRINCIPAL_INVESTIGATOR
Kansas City VA Hospital
Madhav Desai, MD
STUDY_DIRECTOR
Kansas City VA Hospital

Study Locations (Sites)

Kansas City VA Hospital
Kansas City, Missouri, 64128
United States

Collaborators and Investigators

Sponsor: Midwest Veterans' Biomedical Research Foundation

  • Prateek Sharma, MD, PRINCIPAL_INVESTIGATOR, Kansas City VA Hospital
  • Madhav Desai, MD, STUDY_DIRECTOR, Kansas City VA Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15
Study Completion Date2025-04

Study Record Updates

Study Start Date2022-02-15
Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

  • Gastro Esophageal Reflux