Nasal Septum; Deviation, CongenitalNCT04891263
Suture-based, Minimally Invasive Technique Used to Correct NSD
A study testing Suture-Septoplasty and Surgical suture in people with Nasal Septum; Deviation, Congenital and Nasal Obstruction, run by Stanford University at 2 sites in United States.
Trial summary
Nasal Septal Deviation (NSD) is one of the most common indications for surgery seen by ENT physicians, however, correction requires open surgery which is associated with several weeks of recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Septum; Deviation, Congenital, Nasal Obstruction
- What is being tested?
- Suture-Septoplasty and Surgical suture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2021to 13 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patients from all ethnic and geographic backgrounds within the Stanford Sinus Center with symptomatic NSD
- Primary patients with NSD without past septum surgery
- Patients who have failed maximum medical therapy
- Patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon
Who cannot join
- Age < 18
- Recent surgery of any kind (<1 month)
- Inpatients
- Previous nasal septum surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Ambulatory Surgery Center, Stanford Hospital
Palo Alto, California, 94304
Stanford Sinus Center/ Adult Comprehensive ENT Clinic
Stanford, California, 94305
About this study
Official title: Safety and Efficacy of Suture-Septoplasty for Chronic, Durable Correction of Nasal Septal Deviation Causing Nasal Obstruction Symptoms
Nasal Septal Deviation (NSD) is one of the most common indications for surgery seen by ENT physicians, however, correction requires open surgery which is associated with several weeks of recovery. The purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address NSD.
Read the detailed description
Nasal obstruction due to structural issues such as nasal septal deviation (NSD) is remarkably common. NSD is caused by warping of the midline cartilage and bone of the septum, which starts between the 2 nostrils, and extends 7 cm posteriorly to the nasopharynx. This crooked or deviated conformation in the nasal septum cartilage and/or bone leads to physical blockade of normal airflow through the nose, often leading to complaints of nasal congestion, sleep disturbance, exercise limitations, and even poor compliance with CPAP mask use for treatment of obstructive sleep apnea (OSA). To correct this structural issue in symptomatic patients, septoplasty surgery under general anesthesia is typically advocated.
As an alternative to standard septoplasty, there are rare reports of simplified suture techniques that may be used to straighten the nasal septal cartilage. However, virtually all published studies to our knowledge have still required 1) some degree of cartilage/bone excision, which can destabilize the nasal support framework, and 2) use of non-locking sutures which can break, provide insufficient support, and be technically challenging given that it requires knot tying within the narrow nasal cavity corridors.
The investigators have demonstrated in benchtop models that similar results to standard septoplasty techniques can may be achieved with the use of a non-retractable suture without the need for cartilage excision. This technique, therefore, could allow for a simple, and knotless, minimally invasive way to improve and/or correct symptomatic NSD.
- Being tested
- Suture-Septoplasty, Surgical suture
- Keywords
- septoplasty, suture-septoplasty, excisional septoplasty
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture-SeptoplastyProcedure or surgery
Patients receive suture-septoplasty for repair of nasal septal deviation.
Surgical sutureDevice
Also called PDS suture
Suture used for closure during septoplasty surgery.
| Study group | Role | What they receive |
|---|---|---|
| Suture-Septoplasty | Experimental | Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively. Receives: Procedure: Suture-Septoplasty; Device: Surgical suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction Symptom Evaluation (NOSE) score
Unabbreviated scale title: Nasal Obstruction Symptom Evaluation. Mean change from baseline. Minimum value = 0, maximum value = 100. Higher score indicates a worse outcome.
Measured: baseline, month 3
Secondary outcomes (1)
Sino-Nasal Outcome Test (SNOT)-22 score
Unabbreviated scale title: Sino-Nasal Outcome Test. Mean change from baseline. Minimum value = 0, maximum value = 110. Higher score indicates a worse outcome.
Measured: baseline, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start2 Aug 2021
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Why it stopped: Recruitment difficulties due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nasal Septum; Deviation, CongenitalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayakar Nayak, Stanford University
- Investigators
- Jayakar V Nayak, M.D., Ph.D., Principal investigator, Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891263
- Sponsor's protocol ID
- 57545
- Status last verified
- Mar 2023
- First submitted
- 13 May 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only research personal listed in the IRB will have full access to PHI upon approval of the protocol director. All other participants conducting research pertaining to this study will receive anonymous information related to patient outcome that will not be linked to a patient identifier (including participant ID numbers).
Publications
van Egmond MMHT, Rovers MM, Hannink G, Hendriks CTM, van Heerbeek N. Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial. Lancet. 2019 Jul 27;394(10195):314-321. doi: 10.1016/S0140-6736(19)30354-X. Epub 2019 Jun 18.
PubMed 31227374Tan KH. Long-term survey of prominent ear surgery: a comparison of two methods. Br J Plast Surg. 1986 Apr;39(2):270-3. doi: 10.1016/0007-1226(86)90100-1.
PubMed 3697576Rigg BM. Suture materials in otoplasty. Plast Reconstr Surg. 1979 Mar;63(3):409-10. doi: 10.1097/00006534-197903000-00022.
PubMed 154115Boenisch M, Mink A. Clinical and histological results of septoplasty with a resorbable implant. Arch Otolaryngol Head Neck Surg. 2000 Nov;126(11):1373-7. doi: 10.1001/archotol.126.11.1373.
PubMed 11074836Gruber RP, Nahai F, Bogdan MA, Friedman GD. Changing the convexity and concavity of nasal cartilages and cartilage grafts with horizontal mattress sutures: part I. Experimental results. Plast Reconstr Surg. 2005 Feb;115(2):589-94. doi: 10.1097/01.prs.0000150145.39509.db.
PubMed 15692369Gruber RP, Nahai F, Bogdan MA, Friedman GD. Changing the convexity and concavity of nasal cartilages and cartilage grafts with horizontal mattress sutures: part II. Clinical results. Plast Reconstr Surg. 2005 Feb;115(2):595-606; discussion 607-8. doi: 10.1097/01.prs.0000150146.04465.81.
PubMed 15692370Seo HJ, Denadai R, Vamvanij N, Chinpaisarn C, Lo LJ. Primary Rhinoplasty Does Not Interfere with Nasal Growth: A Long-Term Three-Dimensional Morphometric Outcome Study in Patients with Unilateral Cleft. Plast Reconstr Surg. 2020 May;145(5):1223-1236. doi: 10.1097/PRS.0000000000006744.
PubMed 32332542Rohrich RJ, Friedman RM, Liland DL. Comparison of otoplasty techniques in the rabbit model. Ann Plast Surg. 1995 Jan;34(1):43-7. doi: 10.1097/00000637-199501000-00009.
PubMed 7702300Boenisch M, Tamas H, Nolst Trenite GJ. Influence of polydioxanone foil on growing septal cartilage after surgery in an animal model: new aspects of cartilage healing and regeneration (preliminary results). Arch Facial Plast Surg. 2003 Jul-Aug;5(4):316-9. doi: 10.1001/archfaci.5.4.316.
PubMed 12873869
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Suture-Septoplasty for Chronic, Durable Correction of Nasal Septal Deviation Causing Nasal Obstruction Symptoms
- ClinicalTrials.gov ID
- NCT04891263
- Acronym / sponsor ID
- 57545
- Keywords
- septoplasty, suture-septoplasty, excisional septoplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties due to COVID-19 pandemic
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 18 May 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 Septal Deviation (NSD) is one of the most common indications for surgery seen by ENT physicians, however, correction requires open surgery which is associated with several weeks of recovery. The purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address NSD.
Detailed description
Nasal obstruction due to structural issues such as nasal septal deviation (NSD) is remarkably common. NSD is caused by warping of the midline cartilage and bone of the septum, which starts between the 2 nostrils, and extends 7 cm posteriorly to the nasopharynx. This crooked or deviated conformation in the nasal septum cartilage and/or bone leads to physical blockade of normal airflow through the nose, often leading to complaints of nasal congestion, sleep disturbance, exercise limitations, and even poor compliance with CPAP mask use for treatment of obstructive sleep apnea (OSA). To correct this structural issue in symptomatic patients, septoplasty surgery under general anesthesia is typically advocated.
As an alternative to standard septoplasty, there are rare reports of simplified suture techniques that may be used to straighten the nasal septal cartilage. However, virtually all published studies to our knowledge have still required 1) some degree of cartilage/bone excision, which can destabilize the nasal support framework, and 2) use of non-locking sutures which can break, provide insufficient support, and be technically challenging given that it requires knot tying within the narrow nasal cavity corridors.
The investigators have demonstrated in benchtop models that similar results to standard septoplasty techniques can may be achieved with the use of a non-retractable suture without the need for cartilage excision. This technique, therefore, could allow for a simple, and knotless, minimally invasive way to improve and/or correct symptomatic NSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suture-Septoplasty | Experimental | Procedure: Suture-Septoplasty, Device: Surgical sutureParticipants will receive suture-septoplasty technique, and will be followed for three months postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Patients from all ethnic and geographic backgrounds within the Stanford Sinus Center with symptomatic NSD
- Primary patients with NSD without past septum surgery
- Patients who have failed maximum medical therapy
- Patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon
Key exclusion criteria (4 listed)
- Age < 18
- Recent surgery of any kind (<1 month)
- Inpatients
- Previous nasal septum surgery
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 |
|---|---|---|
| Suture-SeptoplastyPatients receive suture-septoplasty for repair of nasal septal deviation. | Procedure or surgery | Suture-Septoplasty |
| Surgical sutureAlso: PDS sutureSuture used for closure during septoplasty surgery. | Device | Suture-Septoplasty |
Primary outcome
Nasal Obstruction Symptom Evaluation (NOSE) score
Time frame: baseline, month 3
Unabbreviated scale title: Nasal Obstruction Symptom Evaluation. Mean change from baseline. Minimum value = 0, maximum value = 100. Higher score indicates a worse outcome.
1 secondary outcome
Sino-Nasal Outcome Test (SNOT)-22 score
Time frame: baseline, month 3
Results and safety
The study was stopped early (reason given: Recruitment difficulties due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 31227374van Egmond MMHT, Rovers MM, Hannink G, Hendriks CTM, van Heerbeek N. Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial. Lancet. 2019 Jul 27;394(10195):314-321. doi: 10.1016/S0140-6736(19)30354-X. Epub 2019 Jun 18.
- Background: PubMed 3697576Tan KH. Long-term survey of prominent ear surgery: a comparison of two methods. Br J Plast Surg. 1986 Apr;39(2):270-3. doi: 10.1016/0007-1226(86)90100-1.
- Background: PubMed 154115Rigg BM. Suture materials in otoplasty. Plast Reconstr Surg. 1979 Mar;63(3):409-10. doi: 10.1097/00006534-197903000-00022.
- Background: PubMed 11074836Boenisch M, Mink A. Clinical and histological results of septoplasty with a resorbable implant. Arch Otolaryngol Head Neck Surg. 2000 Nov;126(11):1373-7. doi: 10.1001/archotol.126.11.1373.
- Background: PubMed 15692369Gruber RP, Nahai F, Bogdan MA, Friedman GD. Changing the convexity and concavity of nasal cartilages and cartilage grafts with horizontal mattress sutures: part I. Experimental results. Plast Reconstr Surg. 2005 Feb;115(2):589-94. doi: 10.1097/01.prs.0000150145.39509.db.
- Background: PubMed 15692370Gruber RP, Nahai F, Bogdan MA, Friedman GD. Changing the convexity and concavity of nasal cartilages and cartilage grafts with horizontal mattress sutures: part II. Clinical results. Plast Reconstr Surg. 2005 Feb;115(2):595-606; discussion 607-8. doi: 10.1097/01.prs.0000150146.04465.81.
- Background: PubMed 32332542Seo HJ, Denadai R, Vamvanij N, Chinpaisarn C, Lo LJ. Primary Rhinoplasty Does Not Interfere with Nasal Growth: A Long-Term Three-Dimensional Morphometric Outcome Study in Patients with Unilateral Cleft. Plast Reconstr Surg. 2020 May;145(5):1223-1236. doi: 10.1097/PRS.0000000000006744.
- Background: PubMed 7702300Rohrich RJ, Friedman RM, Liland DL. Comparison of otoplasty techniques in the rabbit model. Ann Plast Surg. 1995 Jan;34(1):43-7. doi: 10.1097/00000637-199501000-00009.
- Background: PubMed 12873869Boenisch M, Tamas H, Nolst Trenite GJ. Influence of polydioxanone foil on growing septal cartilage after surgery in an animal model: new aspects of cartilage healing and regeneration (preliminary results). Arch Facial Plast Surg. 2003 Jul-Aug;5(4):316-9. doi: 10.1001/archfaci.5.4.316.
- Individual participant dataSharing planned: No. Only research personal listed in the IRB will have full access to PHI upon approval of the protocol director. All other participants conducting research pertaining to this study will receive anonymous information related to patient outcome that will not be linked to a patient identifier (including participant ID numbers).
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.
Jayakar V Nayak, M.D., Ph.D. principal investigator
Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture-Septoplasty and Surgical suture in people with Nasal Septum; Deviation, Congenital and Nasal Obstruction, run by Stanford University at 2 sites in United States.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Recruitment difficulties due to COVID-19 pandemic). Results are not available in the source record.
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?
Nasal Obstruction Symptom Evaluation (NOSE) score (time frame: baseline, month 3). 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 NCT04891263, which also lists 9 linked publications.
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 3 Apr 2023.