NCT04891263

Brief 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. The purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address NSD.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

May 13, 2021

Last Update Submit

March 30, 2023

Conditions

Nasal Septum; Deviation, CongenitalNasal Obstruction

Keywords

septoplastysuture-septoplastyexcisional septoplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, month 3

Secondary Outcomes (1)

  • Sino-Nasal Outcome Test (SNOT)-22 score

    baseline, month 3

Study Arms (1)

Suture-Septoplasty

EXPERIMENTAL

Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.

Procedure: Suture-SeptoplastyDevice: Surgical suture

Interventions

Suture-SeptoplastyPROCEDURE

Patients receive suture-septoplasty for repair of nasal septal deviation.

Suture-Septoplasty
Surgical sutureDEVICE

Suture used for closure during septoplasty surgery.

Also known as: PDS suture
Suture-Septoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18
  • Recent surgery of any kind (\<1 month)
  • Inpatients
  • Previous nasal septum surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Ambulatory Surgery Center, Stanford Hospital

Palo Alto, California, 94304, United States

Location

Stanford Sinus Center/ Adult Comprehensive ENT Clinic

Stanford, California, 94305, United States

Location

Related Publications (9)

  • 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.

    PMID: 31227374BACKGROUND

  • Tan 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.

    PMID: 3697576BACKGROUND

  • Rigg BM. Suture materials in otoplasty. Plast Reconstr Surg. 1979 Mar;63(3):409-10. doi: 10.1097/00006534-197903000-00022.

    PMID: 154115BACKGROUND

  • Boenisch 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.

    PMID: 11074836BACKGROUND

  • Gruber 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.

    PMID: 15692369BACKGROUND

  • Gruber 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.

    PMID: 15692370BACKGROUND

  • Seo 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.

    PMID: 32332542BACKGROUND

  • Rohrich 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.

    PMID: 7702300BACKGROUND

  • Boenisch 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.

    PMID: 12873869BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Sutures

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Jayakar V Nayak, M.D., Ph.D.

    Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Neurosurgery at the Stanford University Medical Center

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

August 2, 2021

Primary Completion

September 13, 2021

Study Completion

September 13, 2021

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

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).

Locations

US(2)