NCT04891263

Suture-based, Minimally Invasive Technique Used to Correct NSD

Safety and Efficacy of Suture-Septoplasty for Chronic, Durable Correction of Nasal Septal Deviation Causing Nasal Obstruction Symptoms

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Nasal Septum; Deviation, Congenital
• Nasal Obstruction

Interventions

Type	Name	Description
PROCEDURE	Suture-Septoplasty	Patients receive suture-septoplasty for repair of nasal septal deviation.
DEVICE	Surgical suture	Suture used for closure during septoplasty surgery.

Timeline

• Start date: 2021-08-02
• Primary completion: 2021-09-13
• Completion: 2021-09-13
• First posted: 2021-05-18
• Last updated: 2023-04-03

Locations

2 sites across 1 country: United States