Trial Outcomes & Findings for Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery (NCT NCT02627794)
NCT ID: NCT02627794
Last Updated: 2017-11-17
Results Overview
The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.
TERMINATED
PHASE3
3 participants
Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
2017-11-17
Participant Flow
Unit of analysis: nasal
Participant milestones
| Measure |
Restora™ Steroid Eluting & Silastic Silicone Spacers
This study arm receives both the experimental treatment, a Restora™ Steroid eluting spacer and Silastic Silicone spacer.
Both spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
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Overall Study
STARTED
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3 6
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Overall Study
COMPLETED
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3 6
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery
Baseline characteristics by cohort
| Measure |
Restora™ Steroid Eluting & Silastic Silicone Spacer
n=6 Nose
This arm receives both Restora™ Steroid eluting \& Silastic Silicone spacers.
The Restora™ Steroid eluting and Silastic Silicone Spacers will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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3 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.
Outcome measures
| Measure |
Silastic Silicone Spacer
n=3 Participants
Silastic Silicone spacers are actively being used as the standard of care.
Silastic Silicone Spacer: The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
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Restora™ Steroid Eluting Spacer
n=3 Participants
This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.
Restora™ Steroid eluting spacer: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
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|---|---|---|
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Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer.
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3 Participants
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3 Participants
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SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
90-day sinonasal mucosal inflammation assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
35 and 90-day intraocular pressure (IOP) assessed using applanation tonometry and compared to baseline IOP obtained preoperatively
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
35 and 90-day post ESS incidence of middle meatal synechiae
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
90-day Sinonasal Outcomes Test-22 (SNOT- 22) scores
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
35-day frequency of postoperative interventions, including lyses of adhesions and debridement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
35-day frequency of oral steroid rescue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.Population: Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.
35 days middle turbinate position
Outcome measures
Outcome data not reported
Adverse Events
Silastic Silicone Spacer
Restora™ Steroid Eluting Spacer
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