Trial Outcomes & Findings for Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out (NCT NCT03534362)
NCT ID: NCT03534362
Last Updated: 2020-04-21
Results Overview
To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.
TERMINATED
NA
1 participants
After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.
2020-04-21
Participant Flow
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Participant milestones
| Measure |
Nasopore Group
Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.
Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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Propel Stent Group
Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.
Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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Overall Study
STARTED
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0
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1
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Overall Study
COMPLETED
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0
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1
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
Baseline characteristics by cohort
| Measure |
Nasopore Group
Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.
Nasopore: Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
Propel Stent Group
n=1 Participants
Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.
Propel: Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
Total
n=1 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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Age, Categorical
Between 18 and 65 years
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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Age, Categorical
>=65 years
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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Sex: Female, Male
Female
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
|
Sex: Female, Male
Male
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0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
|
0 Participants
Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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—
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0 participants
n=1 Participants
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0 participants
n=1 Participants
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PRIMARY outcome
Timeframe: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
To compare the incidence of other surgical postoperative complications (diagnosed post-operative cerebrospinal fluid (CSF) leak, epistaxis requiring treatment, adhesions) between Propel stent and Nasopore.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.Population: Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
To ascertain the incidence of surgical complications based on the specific frontal sinus pathology.
Outcome measures
Outcome data not reported
Adverse Events
Nasopore Group
Propel Stent Group
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