Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray

NCT ID: NCT07204158

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2026-02-28

Brief Summary

The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.

Conditions

Nasal Dryness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

subject using the device

Group Type: EXPERIMENTAL

Spray pompe nasal confort

Intervention Type: DEVICE

Seawater solution with hyaluronan

Interventions

Spray pompe nasal confort

Seawater solution with hyaluronan

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• IC1. Male, female over 6 years old.
• IC2 Rhinoscopy score of at least 6, with a dryness symptom score of at least 2.
• IC3. Have a smartphone that can use MILO application, for any patient that wishes to answer the questionnaires on their phone.
• IC4. Patient and/or parent/legal guardian can understand and comply with protocol requirements and instructions.
• IC5. Patient willing to not change their daily habits including but not limited to Smoking, use of fireplace candles, air conditioning, cold air, medication and dehumidifier.
• IC6. Signed informed consent (by patient and/or parent/legal guardian).

Exclusion Criteria

• EC1. Patients taking anticoagulants, over-the-counter or prescription systemic/topical corticosteroids, antibiotics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists, topical or systemic decongestants or any treatment for relieve of nasal symptoms (except acetaminophen) in the two weeks prior to Visit 1 and during the study;
• EC2. Patient with known hyper sensibility to the study treatment;
• EC3. Patients using other nasal sprays, nasal pumps, nasal irrigation/washing devices or nasal oils, creams or gels in the two weeks prior to Visit 1 and during the study;
• EC4. Patients with any dermatological, respiratory or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, nasal polyposis and chronic sinusitis, urticaria or eczema) that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• EC5. Patients with a positive medical history of any significant illness in the 2 weeks preceding the study, which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• EC6. Patients with nasal anatomical anomalies, e.g., severely deviated septum, congenital cleft lip/palate, nasal hemorrhagic diathesis (assessed by principal investigator);
• EC7. Patient that uses cocaine or other inhaled drugs
• EC8. Patients with any clinically significant co-morbid condition that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• EC9. Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial;
• EC10. Women of childbearing age (except menopausal, hysterectomized, and sterilized) are not using effective contraception (oral contraceptives, intra-uterine devices, contraceptive implants, or condoms);
• EC11. A person belonging to a population referred to in articles 64 (incapacitated subjects), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in an emergency) of the MDR 2017/745.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eclevar Medtech

INDUSTRY

Sponsor Role: collaborator

YSLab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-A00666-43

Identifier Type: -

Identifier Source: org_study_id