Trial Outcomes & Findings for Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing (NCT NCT03188822)
NCT ID: NCT03188822
Last Updated: 2023-01-05
Results Overview
Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
12 months
Results posted on
2023-01-05
Participant Flow
Participant milestones
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Overall Study
STARTED
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9
|
|
Overall Study
COMPLETED
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2
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Overall Study
Subjects chose not to attend the SOC 12 month follow up visit
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6
|
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Overall Study
Clinic was closed due to COVID-19 for 12 month follow up visit
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1
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Baseline Characteristics
Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing
Baseline characteristics by cohort
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant
n=9 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Two subjects completed the 12 month follow up
Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=2 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
propel sinus stent frontal sinusotomy side is better
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0 Participants
|
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Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
propel sinus stent frontal sinusotomy side is same
|
1 Participants
|
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Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
propel sinus stent frontal sinusotomy side is worse
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was collected from 3 subjects at 12 months for this outcome.
Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement - Left side
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=3 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Adhesion/Scarring Scale - Left Side
adhesion/scarring Likert scale score of 0
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3 Participants
|
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Adhesion/Scarring Scale - Left Side
adhesion/scarring Likert scale score of 1
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0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was collected from 3 subjects at 12 months for this outcome.
Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=3 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Adhesion/Scarring Scale - Right Side
adhesion/scarring Likert scale score of 0
|
2 Participants
|
|
Adhesion/Scarring Scale - Right Side
adhesion/scarring Likert scale score of 1
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was collected from 3 subjects at 12 months for this outcome.
Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=3 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
|
|---|---|
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Polypoid Edema Scale - Left Side
polypoid edema Likert score 0
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0 Participants
|
|
Polypoid Edema Scale - Left Side
polypoid edema Likert score 1
|
0 Participants
|
|
Polypoid Edema Scale - Left Side
polypoid edema Likert score 2
|
0 Participants
|
|
Polypoid Edema Scale - Left Side
polypoid edema Likert score 3
|
0 Participants
|
|
Polypoid Edema Scale - Left Side
polypoid edema Likert score 4
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was collected from 3 subjects at 12 months for this outcome.
Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=3 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
|
|---|---|
|
Polypoid Edema Scale - Right Side
polypoid edema Likert score 0
|
1 Participants
|
|
Polypoid Edema Scale - Right Side
polypoid edema Likert score 1
|
0 Participants
|
|
Polypoid Edema Scale - Right Side
polypoid edema Likert score 2
|
0 Participants
|
|
Polypoid Edema Scale - Right Side
polypoid edema Likert score 3
|
0 Participants
|
|
Polypoid Edema Scale - Right Side
polypoid edema Likert score 4
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was collected from 3 subjects at 12 months for this outcome.
Frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=3 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Frontal Sinus Opening Size
Left · Yes
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0 Participants
|
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Frontal Sinus Opening Size
Left · No
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3 Participants
|
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Frontal Sinus Opening Size
Right · Yes
|
1 Participants
|
|
Frontal Sinus Opening Size
Right · No
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOdds ratio of frontal sinus roof visualized for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=2 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
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|---|---|
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Visualization of Frontal Sinus Roof
Yes
|
0 Participants
|
|
Visualization of Frontal Sinus Roof
No
|
2 Participants
|
POST_HOC outcome
Timeframe: 30 DaysPopulation: Data was collected from 8 patients at day 30 for this outcome.
Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal
Outcome measures
| Measure |
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid
n=8 Participants
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Bioabsorbable steroid releasing sinus implant: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Bioabsorbable nasal dressing impregnated with steroid: After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
|
|---|---|
|
Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
propel sinus stent frontal sinusotomy side is better
|
2 Participants
|
|
Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
propel sinus stent frontal sinusotomy side is same
|
3 Participants
|
|
Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
propel sinus stent frontal sinusotomy side is worse
|
3 Participants
|
Adverse Events
Bioabsorbable Steroid Releasing Sinus Implant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place