Chronic RhinitisMERIDIENNCT04769596
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis
A study testing NEUROMARK™ System in people with Chronic Rhinitis, run by Neurent Medical at 8 sites in United States.
Trial summary
A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- NEUROMARK™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Feb 2021to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject provides written informed consent, including authorization to release health information.
- Subject is 18 years of age or older at the time of consent.
- Subject has provided a negative pregnancy test (if Subject is a woman of childbearing potential (WOCBP).
- Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.
- Subjects stated willingness to comply with all study procedures, post- treatment care and availability for the duration of the study follow up of 1 year.
- Subject tests negative for active COVID-19 at the start of study screening and continues to be free from COVID-19 symptoms until the time of enrollment/treatment.
- Subject understands and agrees to follow local COVID-19 restrictions (social distancing, face mask, etc.)
Who cannot join
- Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
- Subject is an active smoker or has been a smoker within the last 6 months (patient reported).
- Any physical condition that in the Investigator's opinion would prevent adequate study participation or pose increased risk to the study Subject.
- Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.
- Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results
- Patient presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere significantly with the Subject's participation in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Specialty Physicians Associates
Bethlehem, Pennsylvania, 18017
Alabama Allergy
Birmingham, Alabama, 35242
Colorado ENT
Colorado Springs, Colorado, 80923
Tandem Clinical Research
Marrero, Louisiana, 70072
Ear, Nose, Throat, & Allergy Associates
Puyallup, Washington, 98374
Sacramento ENT
Roseville, California, 95661
Alamo ENT
San Antonio, Texas, 78258
The Centers of Advanced ENT Care
Towson, Maryland, 21204
About this study
Official title: Safety and Efficacy Study of the Neurent Medical NEUROMARK System in Subjects With Chronic Rhinitis A Double-blind, Sham Controlled Study
A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis
Read the detailed description
The MERIDIEN Study is a prospective, multi-center, double-blind, randomized (1:1), sham-controlled, cross-over study to evaluate the safety and efficacy of the NEUROMARK™ System in patients with Chronic Rhinitis.
- Conditions
- Chronic Rhinitis
- Being tested
- NEUROMARK™ System, Sham Device
- Keywords
- Rhinitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROMARK™ SystemDevice
The NEUROMARK™ System is designed to deliver energy to the nasal cavity intended to interrupt nasal nerves aimed to reduce symptoms related to Chronic Rhinitis.
Sham DeviceDevice
A Sham device will be used in the nasal cavity
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subject in this arm will undergo treatment with the NEUROMARK device. Receives: Device: NEUROMARK™ System |
| Sham | Sham comparator | Subjects in this arm will undergo the procedure with a Sham device. At 3 months post treatment these subjects will cross over to Arm 1. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Serious Adverse Events (SAEs) directly attributable to the device
Safety
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start23 Feb 2021
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies 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
- Randomized, Double-blind, Sham Controlled Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurent Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annalise Sorensen, Study director, Neurent Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769596
- Sponsor's protocol ID
- CLP-0005
- Acronym
- MERIDIEN
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of the Neurent Medical NEUROMARK System in Subjects With Chronic Rhinitis A Double-blind, Sham Controlled Study
- ClinicalTrials.gov ID
- NCT04769596
- Acronym / sponsor ID
- MERIDIEN / CLP-0005
- Conditions
- Chronic Rhinitis
- Keywords
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Neurent MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 24 Feb 2021 (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.
A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis
Detailed description
The MERIDIEN Study is a prospective, multi-center, double-blind, randomized (1:1), sham-controlled, cross-over study to evaluate the safety and efficacy of the NEUROMARK™ System in patients with Chronic Rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Sham Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: NEUROMARK™ SystemSubject in this arm will undergo treatment with the NEUROMARK device. |
| Sham | Sham comparator | Device: Sham DeviceSubjects in this arm will undergo the procedure with a Sham device. At 3 months post treatment these subjects will cross over to Arm 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject provides written informed consent, including authorization to release health information.
- Subject is 18 years of age or older at the time of consent.
- Subject has provided a negative pregnancy test (if Subject is a woman of childbearing potential (WOCBP).
- Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.
- Subjects stated willingness to comply with all study procedures, post- treatment care and availability for the duration of the study follow up of 1 year.
Key exclusion criteria (6 listed)
- Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
- Subject is an active smoker or has been a smoker within the last 6 months (patient reported).
- Any physical condition that in the Investigator's opinion would prevent adequate study participation or pose increased risk to the study Subject.
- Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.
- Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results
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 |
|---|---|---|
| NEUROMARK™ SystemThe NEUROMARK™ System is designed to deliver energy to the nasal cavity intended to interrupt nasal nerves aimed to reduce symptoms related to Chronic Rhinitis. | Device | Treatment |
| Sham DeviceA Sham device will be used in the nasal cavity | Device | Sham |
Primary outcome
Frequency of Serious Adverse Events (SAEs) directly attributable to the device
Time frame: 1 month
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Annalise Sorensen study director
Neurent Medical
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROMARK™ System in people with Chronic Rhinitis, run by Neurent Medical at 8 sites in United States.
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 7 inclusion and 6 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of Serious Adverse Events (SAEs) directly attributable to the device (time frame: 1 month). 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 19 Jul 2023.