Trial Outcomes & Findings for Rates of Middle Meatus Synechiae Formation Post ESS (NCT NCT03036735)
NCT ID: NCT03036735
Last Updated: 2018-10-19
Results Overview
Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
35 to 90days
Results posted on
2018-10-19
Participant Flow
Study was terminated prematurely
Participant milestones
| Measure |
Drug Eluding Spacer
Restora Mometasone Furate spacer
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rates of Middle Meatus Synechiae Formation Post ESS
Baseline characteristics by cohort
| Measure |
Drug Eluding Spacer
n=10 Participants
nasal drug eluding spacer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 35 to 90daysPopulation: Study was terminated , funds withdrawn. No data was collected or analyzed.
Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.
Outcome measures
Outcome data not reported
Adverse Events
Steroid Eluting Spacer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Steroid Eluting Spacer
Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side.
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
steroid eluting spacer: The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
|
|---|---|
|
Ear and labyrinth disorders
Study was terminated for lack of funds
|
—
0/0
study was terminated and funds with drawn. No data was obtained.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place