Trial Outcomes & Findings for Healthcare Utilization and Outcomes of FinESS Treatment in the Office (NCT NCT00986830)

NCT ID: NCT00986830

Last Updated: 2020-10-27

Results Overview

The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 ("no problem") to 5 ("problem as bad as it can be"). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

Baseline and 12 months post procedure

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Dilation Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Overall Study STARTED	74
Overall Study Treated	69
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Balloon Dilation Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Overall Study Death	1
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1
Overall Study Unable to access sinus with device	5

Baseline Characteristics

Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Dilation n=69 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Age, Continuous	47.1 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	69 Participants n=5 Participants
Previous sinus surgery	7 Participants n=5 Participants
Affected sinuses Maxillary only	55 Participants n=5 Participants
Affected sinuses Maxillary and anterior ethmoid	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month SNOT-20 scores.

The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 ("no problem") to 5 ("problem as bad as it can be"). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=64 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Sino-Nasal Outcomes Test Baseline	2.3 score on a scale Standard Deviation 0.9
Sino-Nasal Outcomes Test 12-Month follow-up	1.1 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=65 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain Baseline	53.7 score on a scale Standard Deviation 23.9
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain 12-Month Follow-up	20.7 score on a scale Standard Deviation 21.1

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=65 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain Baseline	61.4 score on a scale Standard Deviation 24.0
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain 12-Month Follow-up	24.4 score on a scale Standard Deviation 23.9

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=65 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain Baseline	40.6 score on a scale Standard Deviation 20.3
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain 12-Month Follow-up	15.4 score on a scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=65 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain Baseline	40.6 score on a scale Standard Deviation 22.4
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain 12-Month Follow-up	15.4 score on a scale Standard Deviation 18.6

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=65 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Number of Participants Using Nasal Steroids Baseline	47 Participants
Number of Participants Using Nasal Steroids 12-Month Follow-up	36 Participants

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=65 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Number of Participants Using Antihistamines Baseline	33 Participants
Number of Participants Using Antihistamines 12-Month Follow-up	28 Participants

SECONDARY outcome

Timeframe: Baseline and 12 months post procedure

Population: All treated participants with baseline and 12-month RSI scores. Four participants with blank responses at either interval are considered not evaluable.

The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=61 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Number of Participants Using Antibiotics Baseline	5.5 number of antibiotic courses Standard Deviation 2.5
Number of Participants Using Antibiotics 12-Month Follow-up	2.3 number of antibiotic courses Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline through 12 months post procedure

Population: All enrolled participants. Participants with unsuccessful procedures (sinus could not be accessed and dilated) were followed for 1 week post procedure. Treated participant are evaluated through 12 months post procedure.

Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure.

Outcome measures

Outcome measures
Measure	Balloon Dilation n=74 Participants Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Number of Participants With Device and/or Procedure-related Adverse Events	16 Participants

Adverse Events

Balloon Dilation

Serious events: 0 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Balloon Dilation n=74 participants at risk Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Injury, poisoning and procedural complications Numbness	12.2% 9/74 • Number of events 9 • 12 months post procedure for treated participants. Participants with unsuccessful treatment were followed for 1 week post procedure. Adverse event information was collected on a standardized case report form at each follow-up visit.

Additional Information

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60