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Clinical Trials/CTRI/2015/12/006445
CTRI/2015/12/006445
Other
Phase 1

A preliminary feasibility study to establish safety and efficacy of a Sinucare designed to perform balloon assisted sinus dilation (BSD) in Chronic Rhino sinusitis (CRS) Patients.

InnAccel Acceleration Services0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: null- Chronic Rhinosinusitis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: null- Chronic Rhinosinusitis
Sponsor
InnAccel Acceleration Services
Status
Other
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
InnAccel Acceleration Services

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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