Suture-based, Minimally Invasive Technique Used to Correct NSD

March 30, 2023 updated by: Jayakar Nayak, Stanford University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Ambulatory Surgery Center, Stanford Hospital
      • Stanford, California, United States, 94305
        • Stanford Sinus Center/ Adult Comprehensive ENT Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suture-Septoplasty
Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.
Procedure: Suture-Septoplasty
Patients receive suture-septoplasty for repair of nasal septal deviation.
Device: Surgical suture
Suture used for closure during septoplasty surgery.
Other Names:
  • PDS suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sino-Nasal Outcome Test (SNOT)-22 score
Time Frame: baseline, month 3
Unabbreviated scale title: Sino-Nasal Outcome Test. Mean change from baseline. Minimum value = 0, maximum value = 110. Higher score indicates a worse outcome.
baseline, month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Jayakar V Nayak, M.D., Ph.D., Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2021

Primary Completion (Actual)

September 13, 2021

Study Completion (Actual)

September 13, 2021

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasal Obstruction

Clinical Trials on Suture-Septoplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe