Data collection study on pharyngeal findings in streptococcal infections

Phase 1

• Conditions: Streptococcal infection

• Registration Number: JPRN-jRCTs032190124
• Lead Sponsor: kato Yuji

Brief Summary

Considering frequencies and degrees of AEs,this device will generally be able to use safe if users follow the device's procedures or manuals and understand having possibility of AEs.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-28
• Study Completion: 2020-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

(1) A person who has obtained the written consent of the individual or his (her) proxy (parent) freely in clinical research participation
(2) A person who is 6 years old or older at the enrollment (age that can use the tongue depressor that is a component of the medical device under development)
For pediatric patients, carefully consider your understanding of the research content in consideration of the physique.
(3) Persons who fall into one or more of the following 1) to 5) [excluding those who have chronic symptoms (those that have persisted for more than one week) for 1) to 4)]
1) With a fever of 37.0 degrees or higher (including cases that exceeded 37 degrees in home measurements)
2) Redness, white moss or swelling of tonsils
3) Cervical lymph node enlargement or tenderness
4) Sore throat
5) Patients whose doctor considers the possibility of streptococcal infection such as exposure to streptococcal patients

Exclusion Criteria

(1) Person who has swing tooth
(2) Persons with severe lesions in the oral cavity where clinical research equipment comes into contact
(3) Those who have severe nausea and have been judged by a physician as inappropriate to use clinical research equipment
(4) Persons who have difficulty in taking the open position with clinical research equipment (eg, small body size, clinical research equipment cannot be inserted into the mouth, pain such as temporomandibular disorders, or difficulty in maintaining the open position due to poor compatibility of dentures, etc. )
(5) Persons who are scheduled to participate in other clinical trials (except post-marketing surveillance) between the date of consent acquisition and the end of the trial period, and those who are unable to comply with the clinical study implementation plan and follow-up For social, family, social, geographical reasons)
(6) Those who have a clear understanding of this study among pediatric patients. Also, those who are small in size and cannot insert clinical research equipment into the oral cavity.
(7) Other persons who are judged inappropriate by the doctor responsible for clinical research

Study & Design

• Study Type: Interventional
• Study Design: Not specified