- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467714
Evaluation Of Cloumella Strut Effect In Tip Rotation
November 17, 2008 updated by: Tehran University of Medical Sciences
Evaluation of Cloumella Strut in Maintenance of Tip Rotation
The role of strut in rhinoplasty has been debated for many years and many research has been made over this problem but there is no significant data for descision of surgeon, so this study was designed to evaluate the effect of columellar strut in tip projection and rotation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 19799
- Imam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- RHINOPLASTIC PATIENTS
Exclusion Criteria:
- REVISION SURGERY,
- INCOMPLETE STRIP,
- FACIAL ANOMALY
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
2.5 cm Cartilage as columella strut
|
COLUMELLA STRUT PLACEMENT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TIP ROTATION
Time Frame: 6 month after surgery
|
6 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TIP PROJECTION
Time Frame: 6 month after surgery
|
6 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: mohmad sadeghi, professor, deputy of research of tehran university medical science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
April 29, 2007
First Submitted That Met QC Criteria
April 30, 2007
First Posted (Estimate)
May 1, 2007
Study Record Updates
Last Update Posted (Estimate)
November 18, 2008
Last Update Submitted That Met QC Criteria
November 17, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BS-181351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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