Trial Outcomes & Findings for Global Sinus Surgery Registry (NCT NCT02347943)
NCT ID: NCT02347943
Last Updated: 2024-07-12
Results Overview
Recruitment status
TERMINATED
Target enrollment
252 participants
Primary outcome timeframe
2 years
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
Balloon Sinus Dilation
Subjects who underwent a balloon sinus dilation procedure
|
Endoscopic Sinus Surgery (ESS)
Subjects who underwent a transnasal endoscopic sinus surgery
|
Hybrid
Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
140
|
67
|
45
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
140
|
67
|
45
|
Reasons for withdrawal
| Measure |
Balloon Sinus Dilation
Subjects who underwent a balloon sinus dilation procedure
|
Endoscopic Sinus Surgery (ESS)
Subjects who underwent a transnasal endoscopic sinus surgery
|
Hybrid
Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
|
|---|---|---|---|
|
Overall Study
Study was cancelled
|
140
|
67
|
45
|
Baseline Characteristics
Global Sinus Surgery Registry
Baseline characteristics by cohort
| Measure |
Balloon Sinus Dilation
n=140 Participants
Subjects who underwent a balloon sinus dilation procedure
|
Endoscopic Sinus Surgery (ESS)
n=67 Participants
Subjects who underwent a transnasal endoscopic sinus surgery
|
Hybrid
n=45 Participants
Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.1 Years
STANDARD_DEVIATION 14.83 • n=5 Participants
|
43.3 Years
STANDARD_DEVIATION 14.42 • n=7 Participants
|
43.8 Years
STANDARD_DEVIATION 18.02 • n=5 Participants
|
45.5 Years
STANDARD_DEVIATION 15.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
118 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Due to early cancellation of the study data for this endpoint were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Balloon Sinus Dilation (BSD)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Endoscopic Sinus Surgery (ESS)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Hybrid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Balloon Sinus Dilation (BSD)
n=140 participants at risk
Subjects who underwent a balloon sinus dilation procedure
|
Endoscopic Sinus Surgery (ESS)
n=67 participants at risk
Subjects who underwent a transnasal endoscopic sinus surgery
|
Hybrid
n=45 participants at risk
Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/140
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
pneumonia
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
Other adverse events
| Measure |
Balloon Sinus Dilation (BSD)
n=140 participants at risk
Subjects who underwent a balloon sinus dilation procedure
|
Endoscopic Sinus Surgery (ESS)
n=67 participants at risk
Subjects who underwent a transnasal endoscopic sinus surgery
|
Hybrid
n=45 participants at risk
Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/140
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/140
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
|
Immune system disorders
Hypersensitivity
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Infections and infestations
Folliculitis
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Infections and infestations
Influenza
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Infections and infestations
Sinusitis
|
0.71%
1/140 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Migraine
|
0.00%
0/140
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Sinus headache
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/140
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
|
Vascular disorders
Hypertension
|
0.71%
1/140 • Number of events 1
|
0.00%
0/67
|
0.00%
0/45
|
|
Surgical and medical procedures
Dehiscence in the lamina papyracea
|
0.00%
0/140
|
1.5%
1/67 • Number of events 1
|
0.00%
0/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place