Study for a new minimally invasive system to treat chronic sinusitis

Phase 1/2

• Conditions: Chronic Rhinosinusitis

• Registration Number: CTRI/2015/12/006445
• Lead Sponsor: InnAccel Acceleration Services

Brief Summary

This feasibility study is designed to evaluate the safety and efficacy of a new medical device (Sinucare) for management of chronic rhinosinusitis. The intended use of Sinucare in final form is to perform minimally invasive sinus ostia dilation for patients suffering from chronic Rhinosinusitis. The system has a component (SinuGuide) that can attach to a standard rigid nasal endoscopy to facilitate the introduction of balloon catheters (SinuCath) inside sinus.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• •Patients must be between 18 – 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 doctor’s judgement.
• Patients not co-operating with a standard endoscopic exam (excess movements, hysterics, needing restraints) Pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objectives of the study are to:	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.
•To establish the feasibility of Sinucare for use during nasal endoscopy procedures	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.
•To demonstrate the safety of Sinucare for use in patients undergoing rigid nasal endoscopic procedures	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.
•To demonstrate the efficacy of SInucare in being used to dilate the sinus ostia of paranasal sinuses.	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 Outcome Measures

Name	Time	Method
Secondary Outcomes	•Assess the Sinucare for the usability by a single clinician in an outpatient setting

Trial Locations

Locations (1)

St. Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

St. Johns Medical College Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Balasubramanya AM

Principal investigator

9341229263

balaam@gmail.com