GERD (Gastroesophageal Reflux Disease)RELIEFNCT07624383
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
A study testing Esophageal barrier medical device in people with GERD (Gastroesophageal Reflux Disease) and NERD, run by Cellmedis at 1 site in Poland.
Trial summary
The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease), NERD, Heartburn
- What is being tested?
- Esophageal barrier medical device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 28 May 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms such as heartburn and or regurgitation for at least 6 months prior to the screening visit, confirmed by the investigator
- Exclusion of erosive reflux disease, Barrett esophagus, and other esophageal abnormalities by upper gastrointestinal endoscopy within the last 6 months, confirmed by the investigator based on medical documentation
- No use within 1 month prior to screening of proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and no use within 1 week prior to screening of sucralfate, antacids, or esophageal mucosal protective agents
- Presence of gastroesophageal reflux symptoms that negatively impact quality of life, as subjectively reported by the patient and confirmed by the investigator
- Age 18 years or older at the time of screening
- Women of childbearing potential must not be pregnant confirmed by a negative urine pregnancy test and must not be breastfeeding, or must be of non childbearing potential defined as surgically sterile, physiologically incapable of becoming pregnant, or at least 12 months post menopause
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- Women of childbearing potential with a male partner of reproductive potential must use a highly effective method of contraception from screening until 18 weeks after the last dose of the investigational medical device
- Sexually active men with women of childbearing potential must agree to use barrier contraception such as condoms or abstain from sexual intercourse throughout the study period and for at least 7 days after the last dose of the investigational medical device
- Ability to comply with all aspects of the clinical study
- Male patients eligible for participation in the study.
Who cannot join
- Women who are breastfeeding or have a positive urine pregnancy test at the baseline visit
- Introduction of significant changes in diet or lifestyle during the study period
- Presence of alarm symptoms at baseline including dysphagia or odynophagia, unintentional weight loss greater than 5 percent of baseline body weight, signs of gastrointestinal bleeding, anemia, palpable epigastric mass, or persistent vomiting lasting 7 to 10 days
- Planned use during the study of antibiotics, probiotics, prebiotics, synbiotics, short chain fatty acids, proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and use within 1 week prior to study start of sucralfate, antacids, or esophageal mucosal protective agents
- Diagnosis of a severe disease such as malignancy
- Planned hospitalization for any reason or presence of any severe comorbidity that in the opinion of the investigator constitutes a contraindication to study participation or may compromise patient safety
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- Current or recent history within 1 year prior to randomization of alcohol dependence or substance abuse
- Active psychiatric disorders that in the opinion of the investigator may interfere with compliance with study procedures
- Presence of unstable or uncontrolled cardiovascular disorders, moderate or severe heart failure classified as New York Heart Association class III or IV, or any clinically significant pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine or metabolic disorder, or any other medical condition that in the opinion of the investigator could affect study results or patient safety
- Individuals who are employees of the study site, investigator, contract research organization, or sponsor
- First degree relatives of employees of the study site, investigator, contract research organization, or sponsor
- Individuals unable to attend all study visits or comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical Network
Warsaw, Masovian Voivodeship, 04-501
Tomasz Połeć, +48608337103, tomasz.polec@cellmedis.com
dr.k.lewandowski@icloud.com
About this study
Official title: New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial)
The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients. It will also teach us about safety, tolerability and improvement of patient's quality of life during and after taking medical device. The main questions it aims to answer are:
- Does medical device relieve reflux symptoms?
- Does medical device improve the quality of life of patients with GERD symptoms? Researchers will compare medical device to a placebo (a look-alike substance that contains no drug) to see if medical device works in GERD gastroesophageal reflux disease .
Read more
Participants will:
- Take medical device or a placebo every day (4 times a day) for 14 days
- Stop taking medical device or placebo for 7 days (wash out period)
- Switch the therapy for medical device or placebo for next 14 days
- Visit the clinic 4 times during 35 days of this study for checkups and tests
- Keep a diary of their symptoms and the number of times they use a medical device
- Fill out the form to collect all necessary data.
Read the detailed description
This medical device was developed as a modern therapeutic alternative, offering rapid symptom relief and long-term protective effects on the esophageal mucosa. The introduction of medical device aims to expand the available therapeutic options for patients suffering from GERD symptoms and to support physicians in selecting optimal therapy. Thanks to its innovative formula, medical device can avoid the rising the symptoms, provide improved well-being and reduce the frequency of acute medication use.
- Being tested
- Esophageal barrier medical device, Placebo oral formulation
- Keywords
- gastroesophageal reflux disease, reflux, heartburn, medical device in reflux, regurgitation, quality of life in reflux disease, reflux symptoms, non erosive reflux disease
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Laryngopharyngeal Reflux, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal barrier medical deviceDevice
Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies.
Placebo oral formulationDevice
Also called Placebo, Matching placebo, Inactive comparator formulation
Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind, placebo controlled crossover design to ensure blinding and allow comparative assessment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Followed by Esophageal Barrier Medical Device Arm | Experimental | Participants receive Placebo oral formulation during the first treatment period followed by esophageal barrier medical device during the second treatment period with a washout interval. Receives: Device: Esophageal barrier medical device; Device: Placebo oral formulation |
| Esophageal Barrier Medical Device Followed by Placebo Arm | Experimental | Participants receive esophageal barrier medical device during the first treatment period followed by Placebo oral formulation during the second treatment period with a washout interval. Receives: Device: Esophageal barrier medical device; Device: Placebo oral formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reflux symptom severity score
Change from baseline in patient reported gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total GERD-HRQL score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission
Proportion of patients achieving complete clinical remission of gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Complete remission is defined as a total score of 0 points in questions 1 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: After 14 days of treatment in each treatment period of the crossover study.
Secondary outcomes (7)
Onset and duration of action of the investigational device.
Assessment of the onset and duration of action of the esophageal barrier medical device using a patient reported questionnaire. Onset of action is defined as the subjective relief of heartburn within two predefined time intervals: up to 15 minutes classified as very rapid onset and 16 to 30 minutes classified as rapid onset. Duration of action is defined as the time period free from reflux symptoms following administration of the investigational product.
Measured: During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Proportion of patients with complete clinical remission of heartburn.
Proportion of patients achieving complete clinical remission of heartburn assessed using the GERD-HRQL questionnaire. Complete remission of heartburn is defined as a total score of 0 points in questions 1 to 6 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of heartburn.
Proportion of patients achieving clinical response of heartburn assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total score of questions 1 to 6 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission of regurgitation.
Proportion of patients achieving complete clinical remission of regurgitation assessed using the GERD-HRQL questionnaire. Complete remission of regurgitation is defined as a total score of 0 points in questions 10 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of regurgitation.
Proportion of patients achieving clinical response of regurgitation assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total score of questions 10 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: After 14 days of treatment in each treatment period of the crossover study.
Change in heartburn and regurgitation severity on Likert scale
Change in severity of heartburn and regurgitation assessed using a five point Likert scale. Improvement is defined as a reduction of at least 2 points in the combined symptom severity score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with improvement in quality of life
Proportion of patients achieving improvement in quality of life assessed using the 36 Item Short Form Survey SF 36. Improvement is defined as a reduction of at least 5 points in the total SF 36 score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Measured: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start28 May 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Gastroesophageal Reflux Disease)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional, randomized, double-blind, cross over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellmedis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Network Sp. z o.o.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624383
- Sponsor's protocol ID
- AZ001-01-01 (RELIEF Trial)
- Other IDs
- CIV-PL-26-03-057013
- Acronym
- RELIEF
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy considerations and applicable data protection regulations. Aggregated and anonymized results will be reported in scientific publications. Data may be available from the corresponding author upon reasonable request, subject to institutional approval and data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial)
- ClinicalTrials.gov ID
- NCT07624383
- Acronym / sponsor ID
- RELIEF / AZ001-01-01 (RELIEF Trial)
- Keywords
- gastroesophageal reflux disease, reflux, heartburn, medical device in reflux, regurgitation, quality of life in reflux disease, reflux symptoms, non erosive reflux disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CellmedisIndustry (pharma, biotech, devices)
- Collaborators
- Medical Network Sp. z o.o.
- Study start
- 28 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients. It will also teach us about safety, tolerability and improvement of patient's quality of life during and after taking medical device. The main questions it aims to answer are:
- Does medical device relieve reflux symptoms?
- Does medical device improve the quality of life of patients with GERD symptoms? Researchers will compare medical device to a placebo (a look-alike substance that contains no drug) to see if medical device works in GERD gastroesophageal reflux disease .
Participants will:
- Take medical device or a placebo every day (4 times a day) for 14 days
- Stop taking medical device or placebo for 7 days (wash out period)
- Switch the therapy for medical device or placebo for next 14 days
- Visit the clinic 4 times during 35 days of this study for checkups and tests
- Keep a diary of their symptoms and the number of times they use a medical device
- Fill out the form to collect all necessary data.
Detailed description
This medical device was developed as a modern therapeutic alternative, offering rapid symptom relief and long-term protective effects on the esophageal mucosa. The introduction of medical device aims to expand the available therapeutic options for patients suffering from GERD symptoms and to support physicians in selecting optimal therapy. Thanks to its innovative formula, medical device can avoid the rising the symptoms, provide improved well-being and reduce the frequency of acute medication use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional, randomized, double-blind, cross over study
| Arm | Type | Receives |
|---|---|---|
| Placebo Followed by Esophageal Barrier Medical Device Arm | Experimental | Device: Esophageal barrier medical device, Device: Placebo oral formulationParticipants receive Placebo oral formulation during the first treatment period followed by esophageal barrier medical device during the second treatment period with a washout interval. |
| Esophageal Barrier Medical Device Followed by Placebo Arm | Experimental | Device: Esophageal barrier medical device, Device: Placebo oral formulationParticipants receive esophageal barrier medical device during the first treatment period followed by Placebo oral formulation during the second treatment period with a washout interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms such as heartburn and or regurgitation for at least 6 months prior to the screening visit, confirmed by the investigator
- Exclusion of erosive reflux disease, Barrett esophagus, and other esophageal abnormalities by upper gastrointestinal endoscopy within the last 6 months, confirmed by the investigator based on medical documentation
- No use within 1 month prior to screening of proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and no use within 1 week prior to screening of sucralfate, antacids, or esophageal mucosal protective agents
- Presence of gastroesophageal reflux symptoms that negatively impact quality of life, as subjectively reported by the patient and confirmed by the investigator
- Age 18 years or older at the time of screening
Key exclusion criteria (12 listed)
- Women who are breastfeeding or have a positive urine pregnancy test at the baseline visit
- Introduction of significant changes in diet or lifestyle during the study period
- Presence of alarm symptoms at baseline including dysphagia or odynophagia, unintentional weight loss greater than 5 percent of baseline body weight, signs of gastrointestinal bleeding, anemia, palpable epigastric mass, or persistent vomiting lasting 7 to 10 days
- Planned use during the study of antibiotics, probiotics, prebiotics, synbiotics, short chain fatty acids, proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and use within 1 week prior to study start of sucralfate, antacids, or esophageal mucosal protective agents
- Diagnosis of a severe disease such as malignancy
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 |
|---|---|---|
| Esophageal barrier medical deviceEsophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies. | Device | Esophageal Barrier Medical Device Followed by Placebo Arm, Placebo Followed by Esophageal Barrier Medical Device Arm |
| Placebo oral formulationAlso: Placebo, Matching placebo, Inactive comparator formulationOral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind, placebo controlled crossover design to ensure blinding and allow comparative assessment. | Device | Esophageal Barrier Medical Device Followed by Placebo Arm, Placebo Followed by Esophageal Barrier Medical Device Arm |
Primary outcome
Change in reflux symptom severity score
Time frame: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Change from baseline in patient reported gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total GERD-HRQL score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Proportion of patients with complete clinical remission
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Complete remission is defined as a total score of 0 points in questions 1 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
7 secondary outcomes
Onset and duration of action of the investigational device.
Time frame: During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Proportion of patients with complete clinical remission of heartburn.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of heartburn.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission of regurgitation.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of regurgitation.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Change in heartburn and regurgitation severity on Likert scale
Time frame: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with improvement in quality of life
Time frame: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy considerations and applicable data protection regulations. Aggregated and anonymized results will be reported in scientific publications. Data may be available from the corresponding author upon reasonable request, subject to institutional approval and data sharing agreements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal barrier medical device in people with GERD (Gastroesophageal Reflux Disease) and NERD, run by Cellmedis at 1 site in Poland.
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 10 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Zaorska, MD (+48 602 229 443, anna.zaorska@cellmedis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reflux symptom severity score (time frame: Baseline and after 14 days of treatment in each treatment period of the crossover study.). 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?
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 10 Jul 2026.