Study Summary
This trial will test a device to help people with laryngopharyngeal reflux, a type of acid reflux. The device, called the Reflux Band, is worn around the neck and compresses the upper esophageal sphincter to prevent reflux. The trial will enroll subjects with salivary pepsin positive LPR and will be double blind, meaning that neither the subjects nor the researchers will know who is in the control or experimental groups. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm
- Laryngopharyngeal Reflux (LPR)
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 5 years
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Experimental
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group
72 Total Participants · 2 Treatment Groups
Primary Treatment: External Upper Esophageal Sphincter (UES) Compression Device · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 99 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Cohen, Seth M., Michael J. Pitman, J. Pieter Noordzij, and Mark Courey. 2012. “Management of Dysphonic Patients by Otolaryngologists”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599812440780.
- Shaker, Reza, Arash Babaei, and Sohrab R. Naini. 2014. “Prevention of Esophagopharyngeal Reflux by Augmenting the Upper Esophageal Sphincter Pressure Barrier”. The Laryngoscope. Wiley. doi:10.1002/lary.24735.
- Ruiz, Ryan, Seema Jeswani, Kenneth Andrews, Benjamin Rafii, Benjamin C. Paul, Ryan C. Branski, and Milan R. Amin. 2014. “Hoarseness and Laryngopharyngeal Reflux”. JAMA Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/jamaoto.2013.6533.
- Vakil, Nimish, Sander V. van Zanten, Peter Kahrilas, John Dent, Roger Jones, and the Global Consensus Group. 2006. “The Montreal Definition and Classification of Gastroesophageal Reflux Disease: A Global Evidence-based Consensus”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1572-0241.2006.00630.x.
- Yadlapati, Rena, Jenna Craft, Christopher J. Adkins, and John E. Pandolfino. 2018. “The Upper Esophageal Sphincter Assist Device Is Associated with Symptom Response in Reflux-associated Laryngeal Symptoms”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2018.01.031.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- de Bortoli, Nicola. 2012. “How Many Cases of Laryngopharyngeal Reflux Suspected by Laryngoscopy Are Gastroesophageal Reflux Disease-related?”. World Journal of Gastroenterology. Baishideng Publishing Group Inc.. doi:10.3748/wjg.v18.i32.4363.
- Issing, W.J., M. Gross, and St. Tauber. 2001. “Manifestationen Von Gastroösophagealem Reflux Im Hno-bereich1”. Laryngo-rhino-otologie. Georg Thieme Verlag KG. doi:10.1055/s-2001-16436.
- Slivers SL, Vaezi MF, Vakil MB, et al. Prospective study of upper esophageal sphincter assist device for treating extraesophageal reflux. Otolaryngol Open J. 2016; 2(1): 31-38. doi: 10.17140/OTLOJ-2-109
- 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.
- Litvinov AV. [Method of tracheobronchial spraying of drugs in aerosols]. Vestn Khir Im I I Grek. 1976 Jan;116(1):100-1. No abstract available. Russian.
- Rena Yadlapati 2021. "Reflux Band in Laryngopharyngeal Reflux". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827355.
Frequently Asked Questions
Is recruitment open for this clinical investigation?
"A review of clinicaltrials.gov reveals that this research initiative, first posted on May 7th 2021, is presently recruiting volunteers. This trial was last modified in November 2022." - Anonymous Online Contributor
Are there certain prerequisites that must be met in order to participate in this research trial?
"This research is actively seeking 72 participants between 18-99 years old who suffer from regurgitation, gastric issues. Key qualifications include: being an adult aged 18-99, English or Spanish fluency, regular usage of double dose PPI*, laryngoscopic exam within the last year with a reflux score higher than 7, elevated reflux testing results and fasting pepsin analysis result ≥25 ng/mL (within 4 months or 12 if treatment plan has been changed)*, 8+ weeks suffering from dysphonia, throat clearing, coughs etc., findings on upper endoscopy that are indicative of pathological GERD." - Anonymous Online Contributor
Does this research endeavor accept individuals older than twenty years of age?
"This trial is only open to individuals between 18 and 99 years old; for minors or seniors, there are 15 and 53 studies respectively." - Anonymous Online Contributor