Nasal BlockageInfundSPLNCT05698940
Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy
A study testing Infundibultomy in people with Nasal Blockage and Nasal Obstruction, run by University of Zurich at 1 site in Switzerland.
Trial summary
Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Blockage, Nasal Obstruction, Septum; Deviation
- What is being tested?
- Infundibultomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Mar 2016to 31 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral breathing impairment due to septal deviation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Zurich University Hospital
Zurich, 8091
Michael Soyka, Dr.med., +41 44 255 11 11, michael.soyka@usz.ch
Michael Soyka, Dr.med.
About this study
Official title: Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy/Uncinectomy
Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.
- Conditions
- Nasal Blockage, Nasal Obstruction, Septum; Deviation
- Being tested
- Infundibultomy
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfundibultomyProcedure or surgery
Infundibultomy on one side of patient
| Study group | Role | What they receive |
|---|---|---|
| Infundibulotomy | Active comparator | Infundibulotomy on one side of sinuses Receives: Procedure: Infundibultomy |
| No Infundibultomty | Sham comparator | No Intervention on other side of sinuses Receives: Procedure: Infundibultomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single sided VAS Scores for breathing impairment
Rating of nasal breating on a 0-10 scale
Measured: 3 months
Secondary outcomes (3)
SNOT Score
Quality of Life Measure from 0-110
Measured: 3 months
NOSE Score
Nasal symptom questionnaire
Measured: 3 months
PNIF
Peak Nasal Inspiratory Flow measured in ml/sec
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start29 Mar 2016
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal BlockageStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698940
- Sponsor's protocol ID
- KEK 2015-0356
- Acronym
- InfundSPL
- Status last verified
- Nov 2023
- First submitted
- 27 Dec 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy/Uncinectomy
- ClinicalTrials.gov ID
- NCT05698940
- Acronym / sponsor ID
- InfundSPL / KEK 2015-0356
- Conditions
- Nasal Blockage, Nasal Obstruction, Septum; Deviation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infundibulotomy | Active comparator | Procedure: InfundibultomyInfundibulotomy on one side of sinuses |
| No Infundibultomty | Sham comparator | Procedure: InfundibultomyNo Intervention on other side of sinuses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral breathing impairment due to septal deviation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| InfundibultomyInfundibultomy on one side of patient | Procedure or surgery | Infundibulotomy, No Infundibultomty |
Primary outcome
Single sided VAS Scores for breathing impairment
Time frame: 3 months
Rating of nasal breating on a 0-10 scale
3 secondary outcomes
SNOT Score
Time frame: 3 months
NOSE Score
Time frame: 3 months
PNIF
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infundibultomy in people with Nasal Blockage and Nasal Obstruction, run by University of Zurich at 1 site in Switzerland.
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 0 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single sided VAS Scores for breathing impairment (time frame: 3 months). 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 1 Dec 2023.