Evaluation of a Medical Device Based on Isotonic Seawater... | NCT07204158

NCT07204158

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Eclevar Medtech	INDUSTRY

Label	Type	Description	Intervention Names
subject using the device	Experimental		Device: Spray pompe nasal confort

Name	Type	Description	Arm Group Labels	Other Names
Spray pompe nasal confort	Device	Seawater solution with hyaluronan	subject using the device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of the nasal dryness symptoms	The changes between the baseline and day 7 in the rhinoscopy score will be assessed. The rhinoscopy score is constituted by the sum of the following symptom: dryness, atrophy, redness, oedema of the nasal mucosa and crusting. The clinician will assess each symptom on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).	From enrollment to the end of treatment at 1 week

Secondary Outcomes

Measure	Description	Time Frame
Improvement of the total perceive Nasal symptom relief	The changes between the baseline and day 7 will be assessed using the Rhinitis Sicca Symptom Score (RSSS). The RSSS is constituted by the sum of the following individual symptoms: sensation of dry nose, impairment of nasal breathing/nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, anterior nasal discharge /runny nose, thick nasal discharge, desire to clear one's throat/ dry throat, impairment of smell and impairment of sleep. Patients assessed with each of these symptoms on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).

Eligibility Module

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.