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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01685229
Other study ID # CPR005028
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2012
Est. completion date August 1, 2015

Study information

Verified date February 2019
Source Acclarent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date August 1, 2015
Est. primary completion date April 1, 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Males and females aged 19 or greater

- Diagnosis of Chronic Rhinosinusitis (CRS)

- Failure of appropriate medical management

- Radiographic evidence of inflammation of the paranasal sinuses

- Surgical candidate

- Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures

- Able to read and understand English

Exclusion Criteria:

- Not suitable for balloon dilation for all peripheral sinuses that require treatment

- Clinically significant illness that may interfere with the evaluation of the study

- Patients involved in other clinical studies 30 days prior to study

- Pregnant or lactating females

- Patients unable to adhere to follow-up schedule or protocol requirements

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Balloon sinus dilation
Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.
Drug:
Medical Management
Subjects who select to continue on medical management rather than have a BSD procedure.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.
The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best).
The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.
Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).
Higher score indicates greater improvement.
24 weeks post treatment
Secondary Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks"), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement. 12, 24, and 52 weeks post treatment
Secondary Change in RSDI The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 ("Never") to 4 ("Always") and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.
The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).
12, 24 and 52 weeks post treatment
Secondary Change in SNOT-20 The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.
Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).
Lower score indicates greater improvement.
12 weeks, 24 weeks, 52 weeks post treatment
Secondary Change in Disease-specific Medication Usage 12, 24 and 52 weeks post treatment
Secondary Missed Days Work/School 12, 24 and 52 weeks post treatment
Secondary Number of Sinus-related Medical Care Visits 12 weeks, 24 weeks, 52 weeks post treatment
Secondary Number of Sinus Infections 24 and 52 weeks
Secondary Number of Subjects Requiring Revision for Subjects Electing BSD A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure. 52 weeks
Secondary Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure 52 weeks
Secondary Post-operative Return to Normal Activity (RTNA) 2 weeks post treatment
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