NCT07569939

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
May 2026Jan 2028

First Submitted

Initial submission to the registry

April 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 11, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 29, 2026

Last Update Submit

May 6, 2026

Conditions

Acute PharyngitisViral Sore Throat

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Efficiency

    From visit 1 (day 1) to the last day of use of the study product (day 8)

  • Efficiency

    From visite 1 (day 1) to visit 2 (day 8)

  • Quality of life impact

    From visite 1 (day 1) to visit 2 (day 8)

  • Device defect

    From visit A (day 1) to visit 2 (day 8)

Study Arms (4)

HMG

EXPERIMENTAL

Patients included in the "HMG" arm will receive the medical device of the same name.

Device: HMG

PHN

EXPERIMENTAL

Patients included in the "PHN" arm will receive the medical device of the same name.

Device: PHN

PHR

EXPERIMENTAL

Patients included in the "PHR" arm will receive the medical device of the same name.

Device: PHR

TUR

EXPERIMENTAL

Patients included in the "TUR" arm will receive the medical device of the same name.

Device: TUR

Interventions

HMGDEVICE

Patients included in the "HMG" arm will receive the medical device of the same name.

HMG
PHRDEVICE

Patients included in the "PHR" arm will receive the medical device of the same name.

PHR
TURDEVICE

Patients included in the "TUR" arm will receive the medical device of the same name.

TUR
PHNDEVICE

Patients included in the "PHN" arm will receive the medical device of the same name.

PHN

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bacterial rhinopharyngitis with negative TROD test
  • Effective contraception for female patients of childbearing age
  • Cooperation and sufficient understanding to comply with the requirements of the trial
  • Acceptance of registration in the SI-RIPH database
  • Having received informed information and agreeing to give written consent
  • Affiliated with the French Social Security scheme.

You may not qualify if:

  • Hypersensitivity/previous allergy to any of the product components,
  • Pharyngitis or tonsillitis or acute rhinopharyngitis complicated (phlegmon, acute otitis media, pneumonia…) or severely intolerable cough,
  • Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations,
  • Other ongoing treatments for acute pharyngitis or tonsillitis (local treatment, antibiotics, corticosteroids, antiretroviral…),
  • Comorbidities or health conditions deemed incompatible with the trial by the investigator,
  • Recent otorhinolaryngology surgery (\<6 months),
  • Pulmonary pathology (Chronic Obstructive Pulmonary Disease, asthma…),
  • Immunosuppression (according to patient's report),
  • Pregnant or breastfeeding women,
  • Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

May 11, 2026

Record last verified: 2026-04

Locations

FR(1)