Reflux Band for Acid Reflux in Lung Transplant Patients
(Reflux Band Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Disqualifiers: Sleep apnea, Head/neck surgery, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently being treated with another investigational medical device or drug.
What data supports the effectiveness of the treatment Reflux Band, Reza Band for acid reflux in lung transplant patients?
Research shows that antireflux surgery, which aims to prevent acid reflux, can improve lung function and survival in lung transplant patients. While the Reflux Band is not specifically mentioned, similar treatments that reduce reflux have been effective in this high-risk group.
12345Is the Reflux Band safe for human use?
The Reflux Band, also known as the Reza Band, is an external device used to reduce acid reflux by compressing the upper esophageal sphincter (a muscle at the top of the esophagus). While the study focused on its effectiveness, it implies that the device is generally safe for human use as it is used alongside standard treatments for acid reflux.
678910What makes the Reflux Band treatment unique for acid reflux in lung transplant patients?
The Reflux Band is unique because it is a non-drug treatment that works by applying gentle pressure to the throat to prevent acid from rising, unlike traditional medications that reduce stomach acid production or neutralize it.
1112131415Eligibility Criteria
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.Inclusion Criteria
Patient must be willing and able to provide informed consent
My lung function has been stable since my last two doctor visits.
Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation
+1 more
Exclusion Criteria
I am using a CPAP machine for my sleep apnea.
I have had a stroke or other brain blood vessel issues.
I have a thyroid condition.
+5 more
Participant Groups
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.
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.
Reflux Band is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Reflux Band for:
- Laryngopharyngeal reflux (LPR) disease
🇪🇺 Approved in European Union as Reflux Band for:
- Laryngopharyngeal reflux (LPR) disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UF Health at the University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
Somna Therapeutics, L.L.C.Industry Sponsor
SOMNA THERAPEUTICSCollaborator
References
Outcomes of partial fundoplication for GERD-related allograft decline after lung transplantation. [2023]Gastroesophageal reflux disease contributes to allograft decline secondary to bronchiolitis obliterans after lung transplantation. Antireflux surgery (ARS) slows the decline in lung function related to GERD. ARS operations range from Nissen fundoplications to partial fundoplications, such as the Toupet and Dor. Research in the general population has indicated that partial fundoplication is effective at controlling reflux. We explored lung function and reflux outcomes in a cohort of lung transplant patients who received partial fundoplications.
The prevalence of distal and proximal gastroesophageal reflux in patients awaiting lung transplantation. [2018]To determine the prevalence and proximal extent of gastroesophageal reflux (GERD) in patients awaiting lung transplantation.
Both Pre-Transplant and Early Post-Transplant Antireflux Surgery Prevent Development of Early Allograft Injury After Lung Transplantation. [2018]Antireflux surgery (ARS) has been associated with improved lung transplant outcomes. Pre-transplant ARS has been shown in small studies to improve pulmonary function among transplant candidates with gastroesophageal reflux disease (GERD). Although early post-transplant ARS has been shown to be effective in reducing chronic rejection, the optimal timing of ARS in transplant recipients remains unclear. The aim of this study is to evaluate the time to early allograft injury among lung transplant recipients by timing of ARS.
Proton Pump Inhibitors Independently Protect Against Early Allograft Injury or Chronic Rejection After Lung Transplantation. [2018]Acid reflux has been associated with poor outcomes following lung transplantation. Unlike surgical fundoplication, the role of noninvasive, pharmacologic acid suppression remains uncertain.
Antireflux surgery in the setting of lung transplantation: strategies for treating gastroesophageal reflux disease in a high-risk population. [2019]In lung transplant recipients, GERD is associated with increased incidence of acute rejection, earlier onset of chronic rejection, and higher mortality. Surgical treatment of GERD in lung recipients seems to prevent early allograft dysfunction and improve overall survival. A total (360 degrees) fundoplication is shown to be a safe and effective method for treating GERD in lung transplant recipients and is the authors' procedure of choice, in most cases, for this high-risk patient population. The principal goal should be to minimize reflux of enteric contents that may lead to micro- or macroaspiration events in this complicated group of patients. Perioperative care should involve a multidisciplinary approach, including physicians and other health care providers familiar with the complexities of lung transplant recipients.
Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. [2022]The Reflux Band, an external upper esophageal sphincter (UES) compression device, reduces esophago-pharyngeal reflux events. This study aimed to assess device efficacy as an adjunct to proton pump inhibitor (PPI) therapy in patients with laryngopharyngeal reflux (LPR).
New pharmacological agents for the treatment of gastroesophageal reflux disease. [2018]Proton pump inhibitors (PPIs) are currently the most effective and most widely used agents for gastroesophageal reflux disease (GERD). Despite the efficacy of these agents in healing and symptom relief, a substantial proportion of patients require twice-daily therapy with PPIs, and break-through symptoms cause others to use over-the-counter antacids and histamine 2-receptor antagonists to supplement their PPI therapy. Major strategies that are being pursued include the development of agents that have a faster onset of action for on-demand therapy; have better control of acid secretion, resulting in improved healing in advanced grades of esophagitis and better symptom control; and agents that decrease transient lower esophageal sphincter relaxations (TLESRs), thereby reducing distal acid exposure and weakly acidic refluxate. A number of new pharmaceutical agents are currently undergoing clinical evaluation for the treatment of GERD. These include agents that reduce TLESRs, serotonergic agents/ prokinetics, long-acting PPIs, mucosal protectants, and antigastrin agents. One or more of these agents may be the future of GERD therapy.
New treatment method for refractory gastroesophageal reflux disease (GERD): C-BLART (clip band ligation anti-reflux therapy)-a short-term study. [2023]C-BLART (clip band ligation anti-reflux therapy) has been reported as a new alternative endoscopic treatment for refractory gastroesophageal reflux disease (GERD). This study evaluated the short-term efficacy of C-BLART for controlling GERD symptoms, esophageal acid exposure, esophagitis, and quality of life.
Pharmacokinetic profile of lesogaberan (AZD3355) in healthy subjects: a novel GABA(B)-receptor agonist reflux inhibitor. [2021]Lesogaberan (AZD3355) is a novel reflux inhibitor developed as an add-on treatment to proton pump inhibitors (PPIs) for symptom relief in patients with gastroesophageal reflux disease who have a partial response to PPI therapy.
Rabeprazole: a pharmacologic and clinical review for acid-related disorders. [2019]Rabeprazole is a proton pump inhibitor that can be used in the treatment of acid-peptic-related disorders (gastroesophageal reflux disease [GERD], duodenal ulcer, gastric ulcer, gastric acid hypersecretory syndromes) and Helicobacter pylori. Pharmacodynamic data has demonstrated that rabeprazole, with a high pKa of approximately 5.0, can be activated at a higher pH than other proton pump inhibitors. This possibly results in faster onset of action. Owing to its non-enzymatic pathway of metabolism, rabeprazole is also less influenced by genetic polymorphisms of the CYP2C19, which others proton pump inhibitors are dependent on. In a 2-week, placebo-controlled trial, rabeprazole was both rapid and effective in relieving heartburn on day 1 of therapy and improved other GERD-related symptoms including regurgitation, belching, bloating, early satiety and nausea. For oesophageal reflux disease without erosions both 10 and 20 mg of rabeprazole are equivalent and better than placebo at 2 and 4 weeks. An on-demand approach to non-erosive reflux disease with 10 mg of rabeprazole has also been documented as superior to placebo. Some success in the treatment of extra-oesophageal manifestations of GERD, such as asthma and chronic laryngitis, has also been achieved with rabeprazole. Overall, rabeprazole with very few side effects is a safe and efficacious medication for acid suppression therapy.
Clinical outcome of amrubicin therapy according to the prior chemotherapy sensitivities of extensive small cell lung cancer. [2012]Amrubicin (AMR) is an active agent for relapsed small cell lung cancer (SCLC). However, the activity of AMR in refractory relapsed patients is controversial. The objective of this retrospective analysis was to evaluate the efficacy and safety of AMR as second-line chemotherapy in SCLC, especially refractory relapsed SCLC.
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer. [2022]On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted on the basis of the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multicohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% [95% confidence interval (CI): 26-45], with a median DOR of 5.3 (95% CI: 4.1-6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.
Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review. [2022]Lurbinectedin was approved on June 15, 2020 by the Food and Drug Administration with the brand name ZEPZELCA as the first systematic approved therapy for patients having Small Cell Lung Cancer (SCLC).
Phase II study of amrubicin combined with carboplatin for refractory relapsed small-cell lung cancer: North Japan Lung Cancer Group Trial 0802. [2014]Amrubicin (AMR), a new anthracycline agent, has shown promising results for advanced small-cell lung cancer (SCLC), although the efficacy of AMR alone against refractory relapsed SCLC is insufficient. This study was conducted to evaluate the safety and efficacy of the combination of AMR and carboplatin (CBDCA) in patients with refractory relapsed SCLC.
An overview of lurbinectedin as a new second-line treatment option for small cell lung cancer. [2021]Small cell lung cancer (SCLC) is a highly proliferative, aggressive form of lung cancer that carries a poor prognosis. Recent approvals with new therapeutic options represent the first in more than a decade for SCLC. Lurbinectedin, a newly approved second-line option, is a synthetic alkaloid that covalently binds DNA, generating double-strand breaks, and disrupts DNA-protein interactions and RNA transcription. Lurbinectedin may also modulate the tumor microenvironment by inducing apoptosis of peripheral blood monocytes and tumor associated macrophages, decreasing expression of the inflammatory chemokine (C-C motif) ligand 2 (CCL2) and reducing tumor angiogenesis. A single-arm, open-label, basket trial included 105 patients with SCLC that had received one prior line of therapy. Patients received lurbinectedin 3.2 mg/m2 as an intravenous infusion every 3 weeks, resulting in a response rate of 35.2% and a disease control rate of 68.6%. The response rate was 45% among those with >90 days chemotherapy free interval (CTFI) and 22% in the resistant group (CTFI < 90 days). The median overall survival was 9.3 months. Myelosuppression is the most frequent clinically significant adverse event, particularly neutropenia; however, neutropenic fever occurred in only 5% of those in the SCLC cohort of the basket trial. Nausea and fatigue were also noted. The side effect profile compares favorably to topotecan, while a direct comparison of tolerability can be made between lurbinectedin versus topotecan or pegylated-liposomal doxorubicin from CORAIL, a randomized study for platinum-resistant/refractory ovarian cancer. A press release has reported the ongoing clinical trial for SCLC including combination lurbinectedin and doxorubicin versus topotecan or cyclophosphamide, doxorubicin, and vinblastine to be negative. The details may provide more insight at publication, and future trials will be important to further define the clinical utility of lurbinectedin. Lurbinectedin represents a new option in second-line SCLC.