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NCT01225250 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
A NA study of Rhinoplasty, sponsored by DeNova Research.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01225250: Completed NA study of Rhinoplasty, sponsored by DeNova Research.
NCT01225250 is a NA study of Rhinoplasty that has completed, run by DeNova Research. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01225250, a NA study of Rhinoplasty, has completed, sponsored by DeNova Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.
Primary Outcome
Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied). Scores closer to 1 indicate a more favorable outcome
Conditions Studied
Interventions
- DEVICE Polydioxanone (PDS) plates
- PROCEDURE Caudal septal extension graft performed through endonasal rhinoplasty
Study Locations (1)
Illinois
- DeNova Research - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-11-24 |
| Est. Completion | 2015-01-19 |
| Phase | NA |
What the finished NCT01225250 record still lists
NCT01225250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Rhinoplasty appearing as the primary indexed condition, and to 2 interventions - of which Polydioxanone (PDS) plates is the first listed.
NCT01225250 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01225250 about?
NCT01225250 is a clinical study titled "Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty". The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.
What is the current status of trial NCT01225250?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2010-11-24. Estimated completion is 2015-01-19.
What conditions does trial NCT01225250 study?
This clinical trial studies the following conditions: Rhinoplasty.
What interventions are being tested in trial NCT01225250?
The interventions under investigation include: Polydioxanone (PDS) plates (DEVICE), Caudal septal extension graft performed through endonasal rhinoplasty (PROCEDURE).
Who is sponsoring clinical trial NCT01225250?
This trial is sponsored by DeNova Research, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01225250 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01225250's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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