Last updated: 01/19/2022 05:30:06
Questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study to Assess the Safety and Effectiveness of Nasal Aspirator and Disposable Nozzle Refills (Hard and Soft Nozzle)
GSK study ID
217866
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observational, questionnaire-based, Post-Market Clinical Follow-Up (PMCF) Study for Nasal Aspirators and Disposable Nozzle Refills (Hard and Soft Nozzles)
Trial description: The purpose of this study is to confirm the safety and performance of Nasal Aspirator and Disposable Nozzle Refills (Hard and Soft Nozzle) in participants experiencing nasal obstruction.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of Participants who Reported Adverse Event or Device Malfunction in Previous 6 Months
Timeframe: 6 months prior to completing the online questionnaire
Percentage of Participants Reporting Satisfaction
Timeframe: 6 months prior to completing the online questionnaire
Secondary outcomes:
Not applicable
Interventions:
Device: Nasal Aspirator and Disposable Nozzle Refills with Hard Nozzle
Device: Nasal Aspirator and Disposable Nozzle Refills with Soft Nozzle
Enrollment:
1170
Observational study model:
Ecologic or Community
Primary completion date:
2021-29-12
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Common cold
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2021 to December 2021
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
0 - 0 Not applicable
Accepts healthy volunteers
No
- Participant (parent/guardian/caregiver over the age of 18 years old) is reasonably able to operate an electronic resource (for example, access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Infants or babies (including babies less than [<]2 weeks old) or children (parent/guardian/caregiver over the age of 18 years old) or adults (including pregnant and breastfeeding woman) who have been treated with the medical devices.
- Participant (parent/guardian/caregiver over the age of 18 years old) is unable to operate an electronic resource (access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (parent/guardian/caregiver over the age of 18 years old) has not used the Nasal Aspirator and Disposable Nozzle Refills (Hard and Soft Nozzle) in the previous 6 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant (parent/guardian/caregiver over the age of 18 years old) is reasonably able to operate an electronic resource (for example, access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Infants or babies (including babies less than [<]2 weeks old) or children (parent/guardian/caregiver over the age of 18 years old) or adults (including pregnant and breastfeeding woman) who have been treated with the medical devices.
- Adults who have used the medical device in the previous 6 months.
Exclusion criteria:
- Participant (parent/guardian/caregiver over the age of 18 years old) is unable to operate an electronic resource (access to computer, smartphone or tablet and sufficient Internet access to connect to study platform) and complete the questionnaire in an electronic format.
- Participant (parent/guardian/caregiver over the age of 18 years old) has not used the Nasal Aspirator and Disposable Nozzle Refills (Hard and Soft Nozzle) in the previous 6 months.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2021-29-12
Actual study completion date
2021-29-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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