An interventional study of Reza band in Laryngopharyngeal Reflux, sponsored by Medical College of Wisconsin. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-08.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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Among 26 studies in Laryngopharyngeal Reflux with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Laryngopharyngeal Reflux · United States.
Among the 26 studies in Laryngopharyngeal Reflux with a site in United States, this one is the 18th largest by enrollment of the 21 interventional ones that give a count, is the only one that started in 2020, is one of 9 with no phase, and was the 20th registered.
56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.
Browse Laryngopharyngeal Reflux studies →3 of the 26 studies in Laryngopharyngeal Reflux with a site in United States are open now. Recruiting first, the newest first:
Medical College of Wisconsin · Sites in United States
Ages 18–64
University of California, San Diego · Sites in United States
Ages 18–89
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Laryngopharyngeal Reflux studies recruiting now, 1 sets no upper age limit and 2 stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 2 · Phase 4 7
First in 2003; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 43 across the 21 interventional studies, 45 across the 5 observational. Of the 15 that completed or were terminated, 8 (53%) have results posted.
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4 of 26 have an industry lead sponsor. The 10 most frequent:
Medical College of Wisconsin is the lead sponsor of 549 studies on the registry; 123 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Medical College of Wisconsin has 2 studies filed under Laryngopharyngeal Reflux — fewer than ten, so there is no comparison to draw.
1 of the studies in Laryngopharyngeal Reflux with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04383262Medical College of WisconsinFosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction | 2027-07-01 |
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Among the 26 studies in Laryngopharyngeal Reflux with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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We hypothesize that tissue and salivary pepsin will resolve after 12 weeks use of Reza Band, but not following standard of care alone. Additionally, RFS, RSI and inflammatory cytokines (IL -1β, -6, and -8) will decrease to normative levels following 12 weeks use of Reza Band, but not with standard of care alone.
Primary Objective The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines.
The long-term goal is to determine the efficacy of the Reza Band in the sequential progression of reflux-attributed laryngeal inflammatory and neoplastic disease.
We propose a prospective cohort study. Sixty patients ≥ 18 years of age presenting to our laryngology outpatient clinic with LPR, with an RFS ≥ 7 and an RSI ≥ 13, not on anticoagulants, able to tolerate an endoscopy and consent to participate in this research study will be included. The study will consist of two cohorts. Cohort one will receive standard care (n = 30), and cohort two will receive standard care plus the Reza Band (to be worn as recommended by the manufacturer; n = 30). Patients will be assigned to either of the cohorts, based on their preferences.
Two laryngeal (posterior cricoid) biopsy specimens (one for pepsin ELISA and the other for qPCR for IL -1β, -6, and -8 inflammatory cytokines) and a throat saliva sample (for pepsin ELISA) will be obtained pre- and posttreatment (12 weeks) in an ambulatory clinic setting. The RSI, a patient-reported symptom severity questionnaire, will be administered in the clinic pre- and posttreatment. (36) Patients will be instructed to cough and clear the back of their throat to provide a saliva sample prior to endoscopy. The RFS (37) will be obtained by the study physicians during office endoscopy prior to biopsy. Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 prior to analyses by ELISA and qPCR.
Pepsin ELISA One biopsy per subject will be homogenized in urea lysis buffer and total protein concentration determined as previously described (28). Saliva samples will be cleared by brief centrifugation. Noncompetitive indirect sandwich enzyme-linked immunosorbent assay described previously (35) will be performed to detect pepsin in biopsy homogenate and saliva.
qPCR RNA will be extracted from a second biopsy, DNAsed and reverse transcribed as described (38). Real time polymerase chain reaction will be performed in a Viaa7 Real Time PCR System using Taqman Gene Expression Assays targeting IL -1β, -6, and -8, and the housekeeping gene HPRT1 (ThermoFisher Scientific, Waltham, MA).
This pilot study will pave the way for clinical trials of a much-needed therapy for airway reflux. If the hypothesis proves true and the Reza Band resolves pepsin and inflammatory cytokines, and significantly improves endoscopic signs (RFS) and symptoms (RSI) of LPR, these data will also support a clinical trial to assess the utility of the Reza Band in preventing reflux-attributed laryngeal inflammatory and neoplastic disease sequelae. To our knowledge, this is the first study that will use pepsin as a primary outcome measure; it is believed to be a sensitive and specific biomarker for reflux and aspiration.
Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 degrees C prior to analyses by ELISA and qPCR. The tissue and saliva samples will be labeled with patient study ID number and date of collection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A will receive standard of care
Group B will receive standard care plus the Reza band (worn as recommended by the manufacturer)
Device: Reza band
Reza band, a non-medication, non-surgical medical device designed to reduce symptoms of LPR has recently been approved by the FDA. It works by stopping the flow of gastric contents through the upper esophageal sphincter (UES) by increasing the internal pressure of the UES
Change in Tissue and Salivary Pepsin Levels
The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines.
Time frame: The change in Pepsin will be measured pre and post 12 week treatment for LPR +/- Reza band
Plan to share: No — If the decision is made to make individual participant data (IPD) available to other researchers, that data will be completely identified prior to release.
Start is estimated for Jul 2020; primary completion for Nov 2021, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin →