Nose Deformities, AcquiredPhase 4NCT00467714
Evaluation Of Cloumella Strut Effect In Tip Rotation
A Phase 4 study testing rhinoplasty in people with Nose Deformities, Acquired, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nose Deformities, Acquired
- What is being tested?
- rhinoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIran
- Study dates
- Feb 2007to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- RHINOPLASTIC PATIENTS
Who cannot join
- REVISION SURGERY,
- INCOMPLETE STRIP,
- FACIAL ANOMALY
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.
- Conditions
- Nose Deformities, Acquired
- Being tested
- rhinoplasty
- Keywords
- RHINOPLASTY ,ESTHETIC SURGERY
- Medical subject headings
- Nose Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhinoplastyProcedure or surgery
Also called no other name
COLUMELLA STRUT PLACEMENT
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | 2.5 cm Cartilage as columella strut Receives: Procedure: rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIP ROTATION
Measured: 6 month after surgery
Secondary outcomes (1)
TIP PROJECTION
Measured: 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose Deformities, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- mohmad sadeghi, professor, Study director, deputy of research of tehran university medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467714
- Sponsor's protocol ID
- BS-181351
- Status last verified
- Nov 2008
- First submitted
- 29 Apr 2007
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cloumella Strut in Maintenance of Tip Rotation
- ClinicalTrials.gov ID
- NCT00467714
- Acronym / sponsor ID
- BS-181351
- Conditions
- Nose Deformities, Acquired
- Keywords
- RHINOPLASTY ,ESTHETIC SURGERY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Procedure: rhinoplasty2.5 cm Cartilage as columella strut |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- RHINOPLASTIC PATIENTS
Key exclusion criteria (3 listed)
- REVISION SURGERY,
- INCOMPLETE STRIP,
- FACIAL ANOMALY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhinoplastyAlso: no other nameCOLUMELLA STRUT PLACEMENT | Procedure or surgery | 1 |
Primary outcome
TIP ROTATION
Time frame: 6 month after surgery
1 secondary outcome
TIP PROJECTION
Time frame: 6 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohmad sadeghi, professor study director
deputy of research of tehran university medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhinoplasty in people with Nose Deformities, Acquired, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIP ROTATION (time frame: 6 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2008; AzTrials last refreshed its copy on 26 Oct 2026.