Trial Outcomes & Findings for Clinical Evaluation of the Ethmoid Sinus Spacer (NCT NCT01054703)
NCT ID: NCT01054703
Last Updated: 2024-08-06
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Procedural and 6 weeks post-implant
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Ethmoid Sinus Spacer Placement
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of the Ethmoid Sinus Spacer
Baseline characteristics by cohort
| Measure |
Ethmoid Sinus Spacer Placement
n=14 Participants
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Procedural and 6 weeks post-implantOutcome measures
| Measure |
Ethmoid Sinus Spacer Placement
n=14 Participants
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
|
|---|---|
|
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
|
1 participants
|
SECONDARY outcome
Timeframe: 1 wk, 2wk, 4wk, 6wkOutcome measures
Outcome data not reported
Adverse Events
Ethmoid Sinus Spacer Placement
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ethmoid Sinus Spacer Placement
n=14 participants at risk
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
|
|---|---|
|
Skin and subcutaneous tissue disorders
epistaxis
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator shall not issue or disseminate any press release or statement, nor initiate or cause to be initiated any communication of information regarding the clinical trial (written or oral) to the communications media or third parties without the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER