Research Center: DaVinci Research
Location: 2 Medical Plaza Drive, Suite 225 Roseville CA 95661
Lead Researcher: Erika Vasquez
IRB: This study has been reviewed and approved by the Allendale Institutional Review Board
About the Study
Tired of battling a runny nose and congestion day after day? Chronic rhinitis affects many individuals, leading to persistent symptoms that can severely impact daily life. The NEUROMARK System, a Food and Drug Administration (FDA) cleared medical device, offers a new approach by delivering targeted energy to the nasal passages to interrupt nerves that affect mucus production.
This study aims to investigate the effectiveness of the NEUROMARK System in reducing chronic rhinitis symptoms and improving the quality of life for those affected. Join researchers from DaVinci Research to help determine if the NEUROMARK System could potentially provide better relief than current treatments. Your participation could contribute to finding a more effective solution for chronic rhinitis and potentially improve the lives of many others.
Sign up today and be a part of this important research!
Why Participate?
- Participants will receive a new potential treatment for rhinitis at no cost.
- Participants may qualify for compensation.
- Participants may experience improvements in symptoms of rhinitis.
- Participants will be contributing valuable information that may benefit those with rhinitis in the future.
- Participants will be helping to advance medical research.
Your Rights
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- People aged 18 and older who have been experiencing rhinitis symptoms for a minimum of 6 months
- Must not have allergy or intolerance to local anesthetic agents.
- Must not have had sinus or nasal surgery in the last 6 months
- Must not have previously undergone Radio Frequency (RF), cryotherapy, or other surgical interventions for rhinitis
- Must not have an active nasal or sinus infection or nasal mucosal erosion/ulceration
- Must not have rhinitis symptoms caused exclusively by seasonal allergies.
- Must not have plans to undergo an ENT (Ear, Nose, and Throat) procedure within the next 3 months
- Must not have initiated a new sinonasal medication regimen in the last 4 weeks
- Must not have been prescribed any of the following medications: prescribed anticoagulants (e.g., Warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure.
- Must be able and willing to discontinue Ipratropium Bromide (IB) for the duration of the study if currently receiving it.
- Must not have a history of chronic epistaxis (nose bleeding) or have experienced a significant epistaxis event requiring medical intervention in the past 3 months.
- Must not have active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months.
- Must not have been diagnosed with atrophic rhinitis.
- Must not have ever had head and/or neck irradiation.
- Must not have been diagnosed with Sarcoidosis or Wegener’s.
- Must not be currently using a CPAP (Continuous Positive Airway Pressure).
- Must not be currently pregnant if female.
- Must not be participating in another clinical trial.
- Must be able and willing to participate in the study for approximately 20 weeks
More Study Details
The study team will explain the research in its entirety but some details are:
- Participants will be asked to provide written informed consent and comply with all study elements, including demographics, medical history, and eligibility assessment.
- Participants will be asked to undergo assessments such as a urine pregnancy test, endoscopic assessment, and randomization procedure (active or sham).
- Participants will be asked to report any adverse events, provide information on concomitant medications, and complete various questionnaires, including rTNSS, mini-RQLQ, NOSE, and PHQ-9.
About the Research Center:
DaVinci Research
DaVinci Research is an organization dedicated to improving patient health through clinical trial research. We work with innovative pharmaceutical and medical device companies from around the world to bring cutting-edge treatments to people suffering from unresolved medical conditions. We partner with and support local physicians to enroll candidates in these trials at little to no cost to the patient. At DVR, we are advancing medicine, one patient, one study at a time
Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.