Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric AdenectomyAdenotonsillectomy
Sponsor:
Pharmaluce srl
Organization:
Pharmaluce srl
Study Overview
Official Title:
Efficacy and Safety Study of the Medical Device Munatoril Aerosol Combo in the Recovery of Nasal Homeostasis in Pediatric Patients Undergoing Adenoidectomy or Adenotonsillectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril Aerosol Combo in its different modalities of use through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy compared with a hypertonic solution and an over-the-counter isotonic solution control group
The primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution
Endpoints Evaluation of subjective longitudinal differences intragroup over-time change and differences between study group and control group intergroup difference regarding the use of the medical device obtained following the protocol with assessment at 8 15 and 30 days after surgery by Likert Scale Score for tolerability and at 0 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy
In addition there is a recording of any adverse events in both groups at 8 15 and 30 days post-surgery and an inter-group comparative evaluation
Participants Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited Follow-up will last 30 days
The primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution
Endpoints Evaluation of subjective longitudinal differences intragroup over-time change and differences between study group and control group intergroup difference regarding the use of the medical device obtained following the protocol with assessment at 8 15 and 30 days after surgery by Likert Scale Score for tolerability and at 0 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy
In addition there is a recording of any adverse events in both groups at 8 15 and 30 days post-surgery and an inter-group comparative evaluation
Participants Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited Follow-up will last 30 days
Detailed Description:
Sample selection criteria
Inclusion criteria
Patients of either sex aged 2 to 17 years candidates for adenoidectomy or adenotonsillectomy surgery
Acquisition and signing of informed consent by the legal guardian Exclusion criteria
Syndromic patients Patients allergic to any substance in the study formulations Patients who have used intranasal corticosteroids topical or systemic corticosteroids or any intranasal medication in the week prior to study entry
Active respiratory infection in the 2 weeks prior to study entry Patients with a history of chronic epistaxis or immunodeficiency 23 Study exit criteria
For reasons related to study treatment adverse event for reasons related to surgery adverse event for non-treatment-related reasons death due to illness patient transfer to other treatment site for patient-related reasons withdrawal of consent poor compliance for reasons related to compliance with proceduresother protocol violations administrative problems for withdrawal of consent by the patients parents or legal guardians In cases of exit from follow-up there is provision for reporting the exit including the date and reasons for it
Inclusion criteria
Patients of either sex aged 2 to 17 years candidates for adenoidectomy or adenotonsillectomy surgery
Acquisition and signing of informed consent by the legal guardian Exclusion criteria
Syndromic patients Patients allergic to any substance in the study formulations Patients who have used intranasal corticosteroids topical or systemic corticosteroids or any intranasal medication in the week prior to study entry
Active respiratory infection in the 2 weeks prior to study entry Patients with a history of chronic epistaxis or immunodeficiency 23 Study exit criteria
For reasons related to study treatment adverse event for reasons related to surgery adverse event for non-treatment-related reasons death due to illness patient transfer to other treatment site for patient-related reasons withdrawal of consent poor compliance for reasons related to compliance with proceduresother protocol violations administrative problems for withdrawal of consent by the patients parents or legal guardians In cases of exit from follow-up there is provision for reporting the exit including the date and reasons for it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None