WHO ICTRP trial

A post marketing surveillance study to check safety and tolerability of a nasal…

CTRI/2023/02/049831 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2023/02/049831
Public title A post marketing surveillance study to check safety and tolerability of a nasal pack (VELNEZ) after a nasal surgery in pediatric patients.
Scientific title A single centric non-randomized, post marketing surveillance study (PMS) to evaluate safety and tolerability of VELNEZ as a nasal pack as a nasal pack after nasal surgery in pediatric age-group.
Primary sponsor Datt Mediproducts Pvt. Ltd.
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type PMS
Phase Post Marketing Surveillance
Countries India
Conditions Health Condition 1: O- Medical and Surgical
Interventions Intervention1: VELNEZ Nasal pack: VELNEZ is a haemostatic medical device as per list of Medical Device under provision of Sub rule (1) Rules-4 of the Medical Device Rules – 2017 maximum duration of the subject’s participation is 25 days…
Registration date Feb 17, 2023
Target size 21
Secondary IDs DMPL/CIP-007-2022/CT/VN; Version 1.0; Date: 07-Nov-2022
Registry page ctri.nic.in

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