Gastroesophageal RefluxNCT03619811

Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

A study testing Reflux Band® Upper Esophageal Sphincter (UES) Assist Device in people with Gastroesophageal Reflux and Laryngopharyngeal Reflux, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition. Read more about this study

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Gastroesophageal Reflux, Laryngopharyngeal Reflux
What is being tested?: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 13 Jul 2018to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18-89 years male and female,
>8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,
naïve to PPI or able to stop for 8 weeks

Who cannot join

Laryngeal mass lesion on laryngoscopy;
Pregnant;
Unable to consent in English;
Imprisoned;
PPI intolerance;
Contraindication to UESAD use per manufacturer guidelines which include:

Show all 13Show fewer

Patients with implants or implant parts that reside in the area where UESAD is applied.
Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
Patients diagnosed with glaucoma.
Patients who had a malignancy of the neck, including neck surgery.
Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Diego
La Jolla, California, 92037

Other trials in United States

About this study

This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.

Read the detailed description

Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.

Conditions: Gastroesophageal Reflux, Laryngopharyngeal Reflux
Being tested: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
Keywords: esophageal disorders
Medical subject headings: Gastroesophageal Reflux, Laryngopharyngeal Reflux, Esophageal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reflux Band® Upper Esophageal Sphincter (UES) Assist DeviceDiagnostic test
UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.

Study groups in NCT03619811
Study group	Role	What they receive
Symptomatic	Experimental	This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device) Receives: Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Measured: Week 8 (Completion)
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 201830 Jun 2021

First posted8 Aug 2018
Study start13 Jul 2018
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03619811
Sponsor's protocol ID: 18-0205
Status last verified: Aug 2021
First submitted: 19 Jul 2018
Last updated: 20 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Yadlapati R, Pandolfino JE, Greytak M, Cahoon J, Clarke M, Clary M, Fink D, Menard-Katcher P, Vahabzadeh-Hagh AM, Weissbrod P, Gupta S, Kaizer A, Wani S. Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Dig Dis Sci. 2022 Jul;67(7):3045-3054. doi: 10.1007/s10620-021-07172-2. Epub 2021 Jul 18.
PubMed 34275061

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
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Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
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All Gastroesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
ClinicalTrials.gov ID: NCT03619811
Acronym / sponsor ID: 18-0205
Conditions: Gastroesophageal Reflux, Laryngopharyngeal Reflux
Keywords: esophageal disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Study start: 13 Jul 2018 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 8 Aug 2018 (actual)
Results: Posted 20 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Symptomatic	Experimental	Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist DeviceThis study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18-89 years male and female,
>8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,
naïve to PPI or able to stop for 8 weeks

Key exclusion criteria (13 listed)

Laryngeal mass lesion on laryngoscopy;
Pregnant;
Unable to consent in English;
Imprisoned;
PPI intolerance;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reflux Band® Upper Esophageal Sphincter (UES) Assist DeviceUES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.	Diagnostic test	Symptomatic

Primary outcome

Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Time frame: Week 8 (Completion)
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Time frame: Week 4
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.

Results and safety

Results posted to the registry on 20 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symptomatic	43	31

Primary outcome: Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score

Time frame: Week 8 (Completion). Mean (Standard Deviation). Unit: score on a scale

Measure	Symptomatic n = 31
Value	15.5 (10.3)

Population analysed: This analysis includes the participants that completed phase 1 \& 2 of the study.

Primary outcome: Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score

Time frame: Week 4. Mean (Standard Deviation). Unit: score on a scale

Measure	Symptomatic n = 36
Value	21.9 (9.7)

Population analysed: This population completed phase 1.

Adverse events

Time frame: 26 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symptomatic	0 of 43 (0%)	1 of 43 (2.3%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34275061Yadlapati R, Pandolfino JE, Greytak M, Cahoon J, Clarke M, Clary M, Fink D, Menard-Katcher P, Vahabzadeh-Hagh AM, Weissbrod P, Gupta S, Kaizer A, Wani S. Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Dig Dis Sci. 2022 Jul;67(7):3045-3054. doi: 10.1007/s10620-021-07172-2. Epub 2021 Jul 18.
Individual participant dataSharing planned: No

Related trials for Gastroesophageal Reflux

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
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Not yet recruitingPhase 4
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rena Yadlapati, M.D. principal investigator

University of California, San Diego

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score (time frame: Week 8 (Completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03619811, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.