Asian RhinoplastyTPNCT02224001
A New Concept in the Tip Plasty of Asian Rhinoplasty
A study testing The Flag Technique in people with Asian Rhinoplasty, run by Winners Clinic at 1 site in South Korea.
Trial summary
For achieving the desired refinements in Asian patients, sufficient septal cartilage must be needed for the ieal tip projection and lengthening of the nose by the septal extension graft, columellar septal strut graft, and onlay tip graft, shield graft. Read more about this study
- Who is it for?
- Ages 17 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Asian Rhinoplasty
- What is being tested?
- The Flag Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Jun 2014
- Phase
- Interventional
- 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 17 to 74 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary case
- secondary case
Who cannot join
- septal cartilage harvested state
- congenital anomaly in septal cartilage
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Department of Plastic Surgery, Winners Clinic
Gangnamgu, Seoul, 135-893
About this study
Official title: A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage Without Septal Extension Grafts
For achieving the desired refinements in Asian patients, sufficient septal cartilage must be needed for the ieal tip projection and lengthening of the nose by the septal extension graft, columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many cases having insufficient septal cartilages in Asian augmentation rhinoplasty.
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
Read the detailed description
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
- Conditions
- Asian Rhinoplasty
- Being tested
- The Flag Technique
- Keywords
- tip plasty, septal cartilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Flag TechniqueProcedure or surgery
A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
| Study group | Role | What they receive |
|---|---|---|
| Asian rhinoplasty, septal cartilage | Experimental | A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result. Receives: Procedure: The Flag Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
- tip deviation : 1 case
- low tip projection : 1 case
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJan 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asian RhinoplastyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winners Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHEOLHWAN KIM, MD, Principal investigator, Winners Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224001
- Sponsor's protocol ID
- Tip Plasty
- Acronym
- TP
- Status last verified
- Sep 2014
- First submitted
- 21 Aug 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
1.Toriumi, D.M. Augmentation rhinoplasty with autologous cartilage grafting. In Park JI, Toriumi, D.M., eds. Asian Facial Cosmetic Surgery. Philadelphia: Saunders-Elsvier, 2007. 2.Toriumi, D.M. Autologous grafts are worth the extra time. Arch Otolaryngol Head Neck Surg 126:562-564, 2000. 3.Toriumi, D.M., DeRosa J. The Asian nose. In R. J. Rohrich, W. P. Jr. Adams, and J. Ahmad, J. P. Gunter (Eds.), Dallas Rhinoplasty: Nasal Surgery by the Masters, Vol 2, 3rd Ed. St. Louise: Quality Medical, 2014. Pp. 1226-1229. 4.Byrd , H.S., Burt, J.D., Andochick, S., et al. Septal extension grafts: a method for controlling tip projection and shape. Plast Reconstr Surg 100:999-1010, 1997. 5.Rohrich R.J., Kurkjian T.J., Hoxworth R.E., et al. The effect of the columellar strut graft on the nasal tip position in primary rhinoplasty. Plast Reconstr Surg 130:926-932, 2012. Erratum in Plast Reconstr Surg 130:1399, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage Without Septal Extension Grafts
- ClinicalTrials.gov ID
- NCT02224001
- Acronym / sponsor ID
- TP / Tip Plasty
- Conditions
- Asian Rhinoplasty
- Keywords
- tip plasty, septal cartilage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Winners ClinicUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Aug 2014 (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.
For achieving the desired refinements in Asian patients, sufficient septal cartilage must be needed for the ieal tip projection and lengthening of the nose by the septal extension graft, columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many cases having insufficient septal cartilages in Asian augmentation rhinoplasty.
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
Detailed description
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asian rhinoplasty, septal cartilage | Experimental | Procedure: The Flag TechniqueA New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result. |
Who may qualify
- Ages
- 17 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- primary case
- secondary case
Key exclusion criteria (2 listed)
- septal cartilage harvested state
- congenital anomaly in septal cartilage
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 |
|---|---|---|
| The Flag TechniqueA New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result. | Procedure or surgery | Asian rhinoplasty, septal cartilage |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: six months
* tip deviation : 1 case * low tip projection : 1 case
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 12 Sep 2014.
- Background1.Toriumi, D.M. Augmentation rhinoplasty with autologous cartilage grafting. In Park JI, Toriumi, D.M., eds. Asian Facial Cosmetic Surgery. Philadelphia: Saunders-Elsvier, 2007. 2.Toriumi, D.M. Autologous grafts are worth the extra time. Arch Otolaryngol Head Neck Surg 126:562-564, 2000. 3.Toriumi, D.M., DeRosa J. The Asian nose. In R. J. Rohrich, W. P. Jr. Adams, and J. Ahmad, J. P. Gunter (Eds.), Dallas Rhinoplasty: Nasal Surgery by the Masters, Vol 2, 3rd Ed. St. Louise: Quality Medical, 2014. Pp. 1226-1229. 4.Byrd , H.S., Burt, J.D., Andochick, S., et al. Septal extension grafts: a method for controlling tip projection and shape. Plast Reconstr Surg 100:999-1010, 1997. 5.Rohrich R.J., Kurkjian T.J., Hoxworth R.E., et al. The effect of the columellar strut graft on the nasal tip position in primary rhinoplasty. Plast Reconstr Surg 130:926-932, 2012. Erratum in Plast Reconstr Surg 130:1399, 2012.
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.
CHEOLHWAN KIM, MD principal investigator
Winners Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Flag Technique in people with Asian Rhinoplasty, run by Winners Clinic at 1 site in South Korea.
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 2 inclusion and 2 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 12 Sep 2014. 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 South Korea. 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.
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?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224001, which also lists 1 linked publication.
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 12 Sep 2014.