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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00430-51 | Other Identifier | 2026-A00430-51 |
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The objective of this study is to conduct post-marketing clinical follow-up of four products: HMG, PHN, PHR, and TUR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of sore throats related to acute pharyngitis and/or viral-origin tonsillitis, while also assessing the benefit/risk ratio of the products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMG | Experimental | Patients included in the "HMG" arm will receive the medical device of the same name. |
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| PHN | Experimental | Patients included in the "PHN" arm will receive the medical device of the same name. |
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| PHR | Experimental | Patients included in the "PHR" arm will receive the medical device of the same name. |
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| TUR | Experimental | Patients included in the "TUR" arm will receive the medical device of the same name. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMG | Device | Patients included in the "HMG" arm will receive the medical device of the same name. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book | From visit 1 (day 1) to visit 2 (day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency | Clinical improvement (yes/no) defined as a decrease of at least 30% in the "total score for symptoms of sore throats" (STSMG) between baseline and the average of the scores measured during the last 3 days of use of the study product (days 5,6,7). | From visit 1 (day 1) to the last day of use of the study product (day 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont Ferrand | Clermont-Ferrand | 63003 | France |
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| PHN |
| Device |
Patients included in the "PHN" arm will receive the medical device of the same name. |
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| PHR | Device | Patients included in the "PHR" arm will receive the medical device of the same name. |
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| TUR | Device | Patients included in the "TUR" arm will receive the medical device of the same name. |
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| Efficiency |
Clinical improvement (yes/no) at the medical examination: the assessment of pharyngeal erythema and general signs (lymphadenopathy, fever) by comparing the patient's data at inclusion and during the visit on day 8. |
| From visite 1 (day 1) to visit 2 (day 8) |
| Quality of life impact | Change in quality of life measured by four questions before (Day 1) and after (Day 8) use of the study products concerning sleep, daily activities, fatigue, and irritability. Each response will be rated between 0 (not impacted) and 10 (highly impacted) on a visual analog scale. | From visite 1 (day 1) to visit 2 (day 8) |
| Device defect | Device defect assessed by recording any defect in terms of identity, quality, durability, reliability, safety, or performance, malfunction, or user error, or any defect in the information provided by the manufacturer in the electronic record book. | From visit A (day 1) to visit 2 (day 8) |