Health Condition 1: null- Chronic Rhinosinusitis
Conditions
Interventions
Intervention1: SinuCare: Investigational Device under development. Affordable minimally invasive sinus dilation system
Control Intervention1: none: none single arm feasibilty study
Sponsors
InnAccel Acceleration Services
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must be between 18 â?? 60 years of age (Both sexes). • Patients advised for a nasal endoscopy as part of standard of care. • Patient is hemodynamic stable with no bleeding disorders • Patient or a legal representative of the patient must be able to give written consent for the study.
Exclusion criteria
Exclusion criteria: Patients on oral anti-coagulation. Patients on inotropic drugs. Patients with bleeding disorders like hemophilia. Unwilling/ Unable to consent patients. • Patients with nasal polyposis • Enrolled in another interventional ENT clinical study • Grossly abnormal nasal anatomy that would not allow introduction of the Sinucare per doctorâ??s judgement. Patients not co-operating with a standard endoscopic exam (excess movements, hysterics, needing restraints) Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of the study are to: â?¢ To establish the feasibility of Sinucare for use during nasal endoscopy procedures â?¢ To demonstrate the safety of Sinucare for use in patients undergoing rigid nasal endoscopic procedures â?¢ To demonstrate the efficacy of SInucare in being used to dilate the sinus ostia of paranasal sinuses.Timepoint: The outcomes will be assessed at the end of each of the three phases of the study. Monitoring will be done for each patient to note any adverse events or issues with the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes â?¢ Assess the Sinucare for the usability by a single clinician in an outpatient setting â?¢ To report any modifications required in Sinucare design arising from patient variabilities Timepoint: Single encounter. Calculated as a value based on study population at the end of the study | — |
Countries
India
Contacts
Public ContactDr Jagdish Chaturvedi
InnAccel Acceleration Services
Outcome results
None listed