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A randomized controlled study on personalized 3D printed vestibular support used to treat nasal vestibular stenosis

A randomized controlled study on personalized 3D printed vestibular support used to treat nasal vestibular stenosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036532
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal vestibular stenosis

Interventions

Experimental group:expansion by personalized 3D Printed vestibular support
Control group:expansion by silicone tube

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient need 10-70 years old, male or female. 2. The patient with unilateral nasal vestibular stenosis, accompanied by the lateral nasal subjective ventilation disorder, and there are different degree of stenosis at nasal vestibular area (nasal hole/the internal nasal valve area to former nostril) by nasal endoscopy and nasal CT scanning.The patient need surgical treatment.

Exclusion criteria

Exclusion criteria: 1. Bilateral nasal vestibular stenosis patients; 2. Patients with congenital nasal deformity accompanied by severe asymmetry of nose; 3. Patients with acute inflammatory nasal disease; 4. Patients with nasal polyps or tumor;Patients with unstable mental illness; 5. Patients with serious poorly controlled cardiovascular disease and/or diabetes.

Design outcomes

Primary

MeasureTime frame
the ratio of narrow lateral nasal vestibular minimum cross-sectional area to health lateral nasal valve cross-sectional area;

Secondary

MeasureTime frame
VAS score of nasal congestion;VAS score of nostril shape;Nasal resistance;Nasal heating efficiency;Nostril shape parameters;Nasal vestibular shape parameters;

Countries

China

Contacts

Public ContactWang Tao

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

wang_tao_2013@163.com+86 18101871061

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026