Nasal ObstructionRhinomedifonNCT05134831
Medical Rhinoplasty: Evaluation of the Efficacy of Hyaluronic Acid in the Treatment of Internal Nasal Valves.
An observational study of Nasal Obstruction, run by Hospices Civils de Lyon.
Trial summary
Nasal obstruction is a possible complication of rhinoplasty surgery. Several causes can explain it: deviation of the nasal septum, appearance of mucosal flanges inside the nasal cavity, but also collapse of the internal valve by its fragility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Rhinomanometry
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adults Patients presenting a nasal obstruction post (septo)rhinoplasty, caused by an internal valve syndrome, which must benefit from an injection of hyaluronic acid will be included (in the absence of criteria of non-inclusion and after collection of the non-opposition of the patient).
Who may be able to join
- Major patients of all ages:
- Previous rhinoplasty or rhinoseptoplasty surgery
- Carrier of a nasal obstruction by collapsed internal valve
- Requiring an injection of hyaluronic acid in the septo-triangular angle
- Nasal obstruction by internal valve collapse is defined by (all elements must be present):
- Patient complaining of nasal obstruction (uni or bilateral)
Show all 10Show fewer
- Collapse of the internal valve during normal nasal inspiratory effort on physical examination
- Improvement of the collapse and therefore of the nasal obstruction at the Bachmann maneuver during the physical examination
- Rhinomanometric internal valve criteria: area under the curve value on the flow/pressure diagram at the inspiratory phase ABOVE the diagnostic threshold (>18 622)
- Patients who did not object to their participation in the study
Who cannot join
- Patients unable to complete questionnaires and visual scales
- Patients with another cause of associated nasal obstruction:
- Persistent septal deviation
- Mucosal synechiae
- Septal perforation
- Turbinate hypertrophy
Show all 11Show fewer
- Inspiratory collapse of the external valve
- Allergic rhinitis
- Vasomotor rhinitis
- Nasosinus polyposis
- Nasal cavity or cavum tumors
About this study
Official title: Functional Medical Rhinoplasty: Objective Evaluation of the Efficacy of Hyaluronic Acid Injections in the Septo-triangular Angle in the Treatment of Internal Nasal Valves
Nasal obstruction is a possible complication of rhinoplasty surgery. Several causes can explain it: deviation of the nasal septum, appearance of mucosal flanges inside the nasal cavity, but also collapse of the internal valve by its fragility. All surgeons performing rhinoplasty or rhinoseptoplasty are unfortunately confronted with this. Thus, when a rhinoplasty patient complains of postoperative nasal obstruction, the surgeon routinely performs several explorations:
- Inspection of the nasal cavity with a nasofibroscope
- Study of the nasal respiratory flows with a rhinomanometer The results of these 2 explorations allow to determine the cause of the obstruction and if it is explained or not by a collapse of the internal valve.
When internal valve collapse is the cause of postoperative nasal obstruction, few alternatives exist to treat this problem. Revision surgery under general anesthesia is usually necessary, with placement of a cartilage graft (= spreader graft) in the septo-triangular angle to reopen and support it. An alternative treatment is the injection of hyaluronic acid into the septo-triangular angle instead of the cartilage graft placed in the operating room. This option has several advantages: it is performed during the consultation, no general anesthesia is required, the procedure is quick, the cost is much lower, the patient's nasal breathing improves immediately, and the post-procedure follow-up is simple. The aim of our study is therefore to objectively analyze the modification of nasal biomechanics after injection of hyaluronic acid in the septo-triangular angle in patients with internal nasal valve (post (septo)-rhinoplasty). This objective evaluation will be performed with a rhinomanometer, before and after injection. This is a simple, non-invasive measuring device that allows the measurement of the main physical variables governing the biomechanics of the fluids inside the nasal cavity, such as pressure, flow and therefore nasal resistance. The objective proof of such an efficiency will allow a better management of the patients, to universalize the practices, to decrease the cost of the treatment and eventually to bring arguments to the health authorities for the reimbursement of such procedures.
- Conditions
- Nasal Obstruction
- Being tested
- Rhinomanometry
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinomanometryDiagnostic test
At Day 0, before the hyaluronic acid injection, the patient's nasal breathing is assessed by 4-phase rhinomanometry (bilaterally: right nostril AND left nostril).
At Month 1, the patient's nasal breathing is re-assessed by 4-phase rhinomanometry, in the same conditions as Day 0.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of the "inspiratory open loop" on the flow-pressure diagram
Value of the area of the "inspiratory open loop" (on the flow/pressure diagram produced by the rhinomanometer, in the inspiratory phase), and position of this value in relation to the diagnostic threshold of internal valve syndrome.
Measured: change between Day 0 before injection and Month 1 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: issue reglementary
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 Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain-Ali MOJALLAL, MD, Principal investigator, Service de chirurgie plastique, esthétique et reconstructrice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134831
- Sponsor's protocol ID
- 69HCL21_0929
- Acronym
- Rhinomedifon
- Status last verified
- Jan 2024
- First submitted
- 27 Oct 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gagnieur P, Fieux M, Saloner L, Louis B, Vertu-Ciolino D, Mojallal AA. Internal Nasal Valve Collapse Treatment by Endonasal Hyaluronic Acid Injection. Aesthetic Plast Surg. 2025 Apr;49(8):2227-2234. doi: 10.1007/s00266-024-04186-9. Epub 2024 Sep 12.
PubMed 39266682
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Medical Rhinoplasty: Objective Evaluation of the Efficacy of Hyaluronic Acid Injections in the Septo-triangular Angle in the Treatment of Internal Nasal Valves
- ClinicalTrials.gov ID
- NCT05134831
- Acronym / sponsor ID
- Rhinomedifon / 69HCL21_0929
- Conditions
- Nasal Obstruction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: issue reglementary
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 26 Nov 2021 (actual)
- 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.
Nasal obstruction is a possible complication of rhinoplasty surgery. Several causes can explain it: deviation of the nasal septum, appearance of mucosal flanges inside the nasal cavity, but also collapse of the internal valve by its fragility. All surgeons performing rhinoplasty or rhinoseptoplasty are unfortunately confronted with this. Thus, when a rhinoplasty patient complains of postoperative nasal obstruction, the surgeon routinely performs several explorations:
- Inspection of the nasal cavity with a nasofibroscope
- Study of the nasal respiratory flows with a rhinomanometer The results of these 2 explorations allow to determine the cause of the obstruction and if it is explained or not by a collapse of the internal valve.
When internal valve collapse is the cause of postoperative nasal obstruction, few alternatives exist to treat this problem. Revision surgery under general anesthesia is usually necessary, with placement of a cartilage graft (= spreader graft) in the septo-triangular angle to reopen and support it. An alternative treatment is the injection of hyaluronic acid into the septo-triangular angle instead of the cartilage graft placed in the operating room. This option has several advantages: it is performed during the consultation, no general anesthesia is required, the procedure is quick, the cost is much lower, the patient's nasal breathing improves immediately, and the post-procedure follow-up is simple. The aim of our study is therefore to objectively analyze the modification of nasal biomechanics after injection of hyaluronic acid in the septo-triangular angle in patients with internal nasal valve (post (septo)-rhinoplasty). This objective evaluation will be performed with a rhinomanometer, before and after injection. This is a simple, non-invasive measuring device that allows the measurement of the main physical variables governing the biomechanics of the fluids inside the nasal cavity, such as pressure, flow and therefore nasal resistance. The objective proof of such an efficiency will allow a better management of the patients, to universalize the practices, to decrease the cost of the treatment and eventually to bring arguments to the health authorities for the reimbursement of such procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults Patients presenting a nasal obstruction post (septo)rhinoplasty, caused by an internal valve syndrome, which must benefit from an injection of hyaluronic acid will be included (in the absence of criteria of non-inclusion and after collection of the non-opposition of the patient).
Key inclusion criteria (10 listed)
- Major patients of all ages:
- Previous rhinoplasty or rhinoseptoplasty surgery
- Carrier of a nasal obstruction by collapsed internal valve
- Requiring an injection of hyaluronic acid in the septo-triangular angle
- Nasal obstruction by internal valve collapse is defined by (all elements must be present):
Key exclusion criteria (11 listed)
- Patients unable to complete questionnaires and visual scales
- Patients with another cause of associated nasal obstruction:
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 |
|---|---|---|
| RhinomanometryAt Day 0, before the hyaluronic acid injection, the patient's nasal breathing is assessed by 4-phase rhinomanometry (bilaterally: right nostril AND left nostril). At Month 1, the patient's nasal breathing is re-assessed by 4-phase rhinomanometry, in the same conditions as Day 0. | Diagnostic test | – |
Primary outcome
Area under the curve of the "inspiratory open loop" on the flow-pressure diagram
Time frame: change between Day 0 before injection and Month 1 after injection
Value of the area of the "inspiratory open loop" (on the flow/pressure diagram produced by the rhinomanometer, in the inspiratory phase), and position of this value in relation to the diagnostic threshold of internal valve syndrome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 39266682Gagnieur P, Fieux M, Saloner L, Louis B, Vertu-Ciolino D, Mojallal AA. Internal Nasal Valve Collapse Treatment by Endonasal Hyaluronic Acid Injection. Aesthetic Plast Surg. 2025 Apr;49(8):2227-2234. doi: 10.1007/s00266-024-04186-9. Epub 2024 Sep 12.
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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.
Alain-Ali MOJALLAL, MD principal investigator
Service de chirurgie plastique, esthétique et reconstructrice
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Obstruction, run by Hospices Civils de Lyon.
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 10 inclusion and 11 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: withdrawn, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the curve of the "inspiratory open loop" on the flow-pressure diagram (time frame: change between Day 0 before injection and Month 1 after injection). 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 NCT05134831, 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 25 Jan 2024.