Clinical Trials Logo
  1. Home
  2. Nasal Obstruction
  3. NCT05698940
  4. Details
NCT05698940 Clinical Trial

Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

Nasal Obstruction Clinical Trial

— InfundSPL  

Official title:
Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy/Uncinectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05698940
Other study ID # KEK 2015-0356
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2016
Est. completion date December 31, 2024

Study information
Verified date November 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Unilateral breathing impairment due to septal deviation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Infundibultomy
Infundibultomy on one side of patient

Locations
Country Name City State
Switzerland Zurich University Hospital Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Single sided VAS Scores for breathing impairment Rating of nasal breating on a 0-10 scale 3 months
Secondary SNOT Score Quality of Life Measure from 0-110 3 months
Secondary NOSE Score Nasal symptom questionnaire 3 months
Secondary PNIF Peak Nasal Inspiratory Flow measured in ml/sec 3 months
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT04228016 - Efficacy of an Intranasal Stent on Nasal Obstruction at Night N/A
Completed NCT02914236 - Treatment of Nasal Airway Obstruction Using the Aerin Medical Device N/A
Completed NCT02952313 - Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study N/A
Completed NCT01965457 - Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings N/A
Completed NCT00850876 - Heated Humidified Continuous Positive Airway Pressure and Nasal Physiology N/A
Completed NCT03156270 - Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction N/A
Active, not recruiting NCT05099263 - The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL) N/A
Recruiting NCT05573919 - VivAer: A Correlation Between Symptom Scores and Objective Findings N/A
Completed NCT03290300 - Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device
Recruiting NCT04499469 - The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment N/A
Not yet recruiting NCT01702103 - Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays Phase 3
Completed NCT04220853 - Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty N/A
Completed NCT03456115 - A New Treatment for Mechanical Nasal Obstruction N/A
Completed NCT00793117 - The Effect of Packing in Post Operative Management of FESS Phase 4
Completed NCT02964312 - LATERA-OFFICE Study N/A
Recruiting NCT04150783 - Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes
Completed NCT01506583 - Clinical Evaluation of QFlu Combo Test
Recruiting NCT03925389 - Outcome Analysis in Septorhinoplasty
Recruiting NCT05494346 - Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction N/A