Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01684020 | A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty | PHASE2 | COMPLETED | 10 | — | — | Nov 28, 2012 | Apr 26, 2016 | Nov 2, 2020 | 1 | United States |
Measured at Day 1, 7, 30, 180 0 None- No apparent edema 1. Mild- Minimal tissue swelling 2. Moderate- Moderate edema, nasal features still discernible 3. Severe- Marked swelling, difficulty distinguishing nasal features Scores closer to 0 indicate more favorable results
Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.
| Arm | Type | Description |
|---|---|---|
| ARTISS Human Fibrin Sealant | EXPERIMENTAL | Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes. |
| Standard of Care | NO_INTERVENTION | Fixation of the skin flap created during external rhinoplasty will use the standard of care |
| Name | Type | Description |
|---|---|---|
| ARTISS human fibrin sealant | BIOLOGICAL | - |
Inclusion Criteria: 1. Males and females between 18 and 65 years of age. 2. Subjects requesting primary rhinoplasty and requiring an external approach. 3. Subjects willing to undergo treatment with fibrin sealant. 4. Willingness and ability to comply with protocol requirements, including returning ...