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NCT01684020 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
A Phase 2 study, sponsored by DeNova Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01684020: Completed Phase 2 study, sponsored by DeNova Research.
NCT01684020 is a Phase 2 study that has completed, run by DeNova Research. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01684020, a Phase 2 study, has completed, sponsored by DeNova Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the nose to correct a medical problem or change the appearance of the nose. During the healing process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may or may not lessen these effects. This study is looking to see the effects of ARTISS on adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an external approach.
Primary Outcome
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
Interventions
- BIOLOGICAL ARTISS human fibrin sealant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-11-28 |
| Est. Completion | 2016-04-26 |
| Phase | Phase 2 |
What the finished NCT01684020 record still lists
NCT01684020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which ARTISS human fibrin sealant is the first listed.
NCT01684020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01684020 about?
NCT01684020 is a clinical study titled "A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty". Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the nose to correct a medical problem or change the appearance of the nose. During the healing process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may or may not lessen the...
What is the current status of trial NCT01684020?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-11-28. Estimated completion is 2016-04-26.
What interventions are being tested in trial NCT01684020?
The interventions under investigation include: ARTISS human fibrin sealant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01684020?
This trial is sponsored by DeNova Research, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01684020's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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