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Behavioural Intervention

Reflux Band for Acid Reflux in Lung Transplant Patients (Reflux Band Trial)

N/A

Recruiting

Led By Andres Pelaez Freidel, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically stable lung transplant patients (single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; week 4; week 8

Awards & highlights

Reflux Band Trial Summary

This trial looks at whether a device called the Reflux Band can help reduce acid reflux in people who have had a lung transplant.

Who is the study for?

This trial is for lung transplant recipients who have acid reflux, as shown by tests before their transplant. They must understand and agree to the study's process and follow-up visits. Stable lung function after the transplant is required. People with recent head or neck surgery, thyroid disease, certain cancers, carotid artery disease, or a history of stroke can't join.Check my eligibility

What is being tested?

The study is testing the Reflux Band™ UES Assist Device on patients who've had a lung transplant to see if it helps control their acid reflux symptoms. It's an open-label trial where all participants will use the device and be monitored for its effects.See study design

What are the potential side effects?

While not explicitly listed in your information provided, potential side effects may include discomfort at the site of wearing the device, possible skin irritation from contact with the band material, or difficulty swallowing if too much pressure is applied.

Reflux Band Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung function has been stable since my last two doctor visits.

Reflux Band Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; week 4; week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; week 4; week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 4; week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in amylase levels

Change in pepsin levels

Reflux Band Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung Transplant PatientsExperimental Treatment1 Intervention

For the first four weeks, lung transplant patients will not wear the Reflux Band. Use of the Reflux Band will subsequently commence in the next four weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Somna Therapeutics, L.L.C.Industry Sponsor

2 Previous Clinical Trials

115 Total Patients Enrolled

University of FloridaLead Sponsor

1,347 Previous Clinical Trials

720,629 Total Patients Enrolled

SOMNA THERAPEUTICSUNKNOWN

Media Library

Reflux Band (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03886961 — N/A

Acid Reflux Research Study Groups: Lung Transplant Patients

Acid Reflux Clinical Trial 2023: Reflux Band Highlights & Side Effects. Trial Name: NCT03886961 — N/A

Reflux Band (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03886961 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include individuals aged 30 or above?

"Eligible participants for this research must be aged 18 or above and under 80 years of age."

Answered by AI

What is the maximum cohort size for this research study?

"Affirmative, according to clinicaltrials.gov the trial is presently recruiting participants and was initially published on May 17th 2019 with its latest update occurring June 30th 2022. The study seeks 20 volunteers from a single medical site."

Answered by AI

Is there still availability for prospective participants in this trial?

"Affirmative, the clinicaltrials.gov database shows that this trial is currently in progress with recruitment beginning on May 17th 2019 and the last amendment being made June 30th 2022. Twenty patients are needed for enrolment at a single medical facility."

Answered by AI

Who is eligible to join this scientific inquiry?

"To be eligible for this research, potential participants must have been diagnosed with gastroesophageal reflux disease and fall within the 18-80 age range. Currently, a total of 20 individuals are being recruited for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients

2019. "The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03886961.