Study Summary
This trial will examine if the ARAT is an effective and safe treatment for patients with chronic GERD symptoms.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: At 3, 6 and 12 months
Month 12
Beta-Aminoethylisothiuronium Dihydrobromide
Change in Hiatal hernia grading
Esophagitis incidence
Month 12
Change in GERD health related quality of life (GERD-HRQL) score
Change in Proton pump inhibitor (PPI) use
Change in Reflux disease questionnaire (RDQ) score
Day 30
Adverse events
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Anti-reflux mucosal ablation (ARAT)
1 of 2
No treatment
1 of 2
Active Control
Non-Treatment Group
36 Total Participants · 2 Treatment Groups
Primary Treatment: Anti-reflux mucosal ablation (ARAT) · Has Placebo Group · N/A
No treatment
Procedure
ShamComparator Group · 1 Intervention: Sham intervention (control) · Intervention Types: ProcedureAnti-reflux mucosal ablation (ARAT)
Procedure
ActiveComparator Group · 1 Intervention: ARAT · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3, 6 and 12 months
Who is running the clinical trial?
Midwest Veterans' Biomedical Research FoundationLead Sponsor
Prateek Sharma, MDPrincipal InvestigatorKansas City VA Hospital
18 Previous Clinical Trials
8,765 Total Patients Enrolled
Madhav Desai, MDStudy DirectorKansas City VA Hospital
Eligibility Criteria
Age 18 - 80 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have experienced heartburn or acid reflux at least twice a week for the past 6 months.
References
- El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13. Review.
- Peerally MF, Bhandari P, Ragunath K, Barr H, Stokes C, Haidry R, Lovat L, Smart H, Harrison R, Smith K, Morris T, de Caestecker JS. Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett's esophagus: a randomized pilot study (BRIDE). Gastrointest Endosc. 2019 Apr;89(4):680-689. doi: 10.1016/j.gie.2018.07.031. Epub 2018 Aug 1.
- Fayad, Lea, Andreas Oberbach, Michael Schweitzer, Frederic Askin, Lysandra Voltaggio, Tatianna Larman, Markus Enderle, et al.. 2019. “Gastric Mucosal Devitalization (GMD): Translation to a Novel Endoscopic Metabolic Therapy”. Endoscopy International Open. Georg Thieme Verlag KG. doi:10.1055/a-0957-3067.
- Vaezi MF, Yang YX, Howden CW. Complications of Proton Pump Inhibitor Therapy. Gastroenterology. 2017 Jul;153(1):35-48. doi: 10.1053/j.gastro.2017.04.047. Epub 2017 May 19. Review.
- Hillman L, Yadlapati R, Whitsett M, Thuluvath AJ, Berendsen MA, Pandolfino JE. Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease. Dis Esophagus. 2017 Sep 1;30(9):1-14. doi: 10.1093/dote/dox054. Review.
- Taïeb S, Rolachon A, Cenni JC, Nancey S, Bonvoisin S, Descos L, Fournet J, Gérard JP, Flourié B. Effective use of argon plasma coagulation in the treatment of severe radiation proctitis. Dis Colon Rectum. 2001 Dec;44(12):1766-71.
- Manner H, Neugebauer A, Scharpf M, Braun K, May A, Ell C, Fend F, Enderle MD. The tissue effect of argon-plasma coagulation with prior submucosal injection (Hybrid-APC) versus standard APC: A randomized ex-vivo study. United European Gastroenterol J. 2014 Oct;2(5):383-90. doi: 10.1177/2050640614544315.
- Delshad SD, Almario CV, Chey WD, Spiegel BMR. Prevalence of Gastroesophageal Reflux Disease and Proton Pump Inhibitor-Refractory Symptoms. Gastroenterology. 2020 Apr;158(5):1250-1261.e2. doi: 10.1053/j.gastro.2019.12.014. Epub 2019 Dec 19.
- Sami SS, Al-Araji SA, Ragunath K. Review article: gastrointestinal angiodysplasia - pathogenesis, diagnosis and management. Aliment Pharmacol Ther. 2014 Jan;39(1):15-34. doi: 10.1111/apt.12527. Epub 2013 Oct 20. Review.
- Locke, GR, 3rd, NJ Talley, SL Fett, AR Zinsmeister, and LJ Melton 3rd. 1997. “Prevalence and Clinical Spectrum of Gastroesophageal Reflux: A Population-based Study in Olmsted County, Minnesota”. Gastroenterology. Elsevier BV. doi:10.1016/s0016-5085(97)70025-8.
- Maret-Ouda J, Wahlin K, El-Serag HB, Lagergren J. Association Between Laparoscopic Antireflux Surgery and Recurrence of Gastroesophageal Reflux. JAMA. 2017 Sep 12;318(10):939-946. doi: 10.1001/jama.2017.10981.
- Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943.
- Yadlapati R, Vaezi MF, Vela MF, Spechler SJ, Shaheen NJ, Richter J, Lacy BE, Katzka D, Katz PO, Kahrilas PJ, Gyawali PC, Gerson L, Fass R, Castell DO, Craft J, Hillman L, Pandolfino JE. Management options for patients with GERD and persistent symptoms on proton pump inhibitors: recommendations from an expert panel. Am J Gastroenterol. 2018 Jul;113(7):980-986. doi: 10.1038/s41395-018-0045-4. Epub 2018 Apr 24.
- Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.
- Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.
- Witteman BP, Conchillo JM, Rinsma NF, Betzel B, Peeters A, Koek GH, Stassen LP, Bouvy ND. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2015 Apr;110(4):531-42. doi: 10.1038/ajg.2015.28. Epub 2015 Mar 31.
- Hernández Mondragón OV, Zamarripa Mottú RA, García Contreras LF, Gutiérrez Aguilar RA, Solórzano Pineda OM, Blanco Velasco G, Murcio Perez E. Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video). Gastrointest Endosc. 2020 Dec;92(6):1190-1201. doi: 10.1016/j.gie.2020.04.046. Epub 2020 Apr 25.
- Desjardin M, Luc G, Collet D, Zerbib F. 24-hour pH-impedance monitoring on therapy to select patients with refractory reflux symptoms for antireflux surgery. A single center retrospective study. Neurogastroenterol Motil. 2016 Jan;28(1):146-52. doi: 10.1111/nmo.12715. Epub 2015 Nov 3.
- Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005 Aug 2;143(3):199-211.
- Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
- Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Hernandez Mondragon OV, Zamarripa Mottu RA, Garcia Contreras LF, Gutierrez Aguilar RA, Solorzano Pineda OM, Blanco Velasco G, Murcio Perez E. Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video). Gastrointest Endosc. 2020 Dec;92(6):1190-1201. doi: 10.1016/j.gie.2020.04.046. Epub 2020 Apr 25.
- El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
- Sami SS, Al-Araji SA, Ragunath K. Review article: gastrointestinal angiodysplasia - pathogenesis, diagnosis and management. Aliment Pharmacol Ther. 2014 Jan;39(1):15-34. doi: 10.1111/apt.12527. Epub 2013 Oct 20.
- Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005 Aug 2;143(3):199-211. doi: 10.7326/0003-4819-143-3-200508020-00006.
- Vaezi MF, Yang YX, Howden CW. Complications of Proton Pump Inhibitor Therapy. Gastroenterology. 2017 Jul;153(1):35-48. doi: 10.1053/j.gastro.2017.04.047. Epub 2017 May 19.
- Hillman L, Yadlapati R, Whitsett M, Thuluvath AJ, Berendsen MA, Pandolfino JE. Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease. Dis Esophagus. 2017 Sep 1;30(9):1-14. doi: 10.1093/dote/dox054.
- Taieb S, Rolachon A, Cenni JC, Nancey S, Bonvoisin S, Descos L, Fournet J, Gerard JP, Flourie B. Effective use of argon plasma coagulation in the treatment of severe radiation proctitis. Dis Colon Rectum. 2001 Dec;44(12):1766-71. doi: 10.1007/BF02234452.
- 2022. "Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05570448.
Frequently Asked Questions
Is the eligibility for this examination restricted to individuals of a certain age?
"This medical study is currently welcoming participants aged 18 to 80." - Anonymous Online Contributor
Unverified Answer
Who qualifies to participate in this research?
"To be eligible for entry, potential participants must have gastroesophageal reflux and fit within the 18 to 80 age range. As of now, 36 patients are needed for this clinical trial." - Anonymous Online Contributor
Unverified Answer
Are participants still being recruited for this research endeavor?
"The information available on clinicaltrials.gov verifies that recruitment events are taking place for this study. It was initially posted in mid-February and edited most recently during early October of 2022." - Anonymous Online Contributor
Unverified Answer
How many participants have been recruited for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this trial is currently seeking volunteers for participation; it was initially posted on February 15th 2022 and the most recent update occurred October 5th of the same year. The study intends to enroll 36 patients from a single medical centre." - Anonymous Online Contributor
Unverified Answer