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RECRUITING
NCT07861061
NA

Efficacy and Safety of NasoAid® After Nasal Surgery

Sponsor: Maxigen Biotech Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of collagen-based absorbable nasal packing (NasoAid®) after nasal surgery. The main question it aims to answer are: * The hemostasis 2, 12, 24, 48 hours after nasal packing. * The endoscopic nasal assessments scores. * The remnant percentage of nasal packing material. * Patient-reported Visual Analog Scale (VAS) scores for general assessment. * Patient-reported outcomes, including the Sino-Nasal Outcome Test-22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE), and Total Nasal Symptom Score (TNSS). * The incidences of safety indicators. Participants will be randomized into either experiment group or control group, receive nasal packing at Day0, and re-visited on week 1, 2, 4, 8 and 12 after nasal surgery. Researchers will compare if NasoAid® is non-inferiority to NasoPore.

Official title: Efficacy and Safety of Collagen-Based Absorbable Nasal Packing (NasoAid®) After Nasal Surgery: A Prospective, Single-Blind, Randomized Controlled Multi-Center Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2026-08-24

Completion Date

2027-07-31

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DEVICE

NasoAid® Intranasal Splint

NasoAid® Intranasal Splint is an absorbable nasal packing device composed of collagen and carboxymethyl cellulose. Nasal packing will be applied at the end of surgery. The packing may be trimmed or reshaped intraoperatively by the surgeon to fit the cavity.

DEVICE

"Stryker" NasoPore Nasal Dressing

"Stryker" NasoPore Nasal Dressing is a bioresorbable synthetic polyurethane foam nasal packing device. Nasal packing will be applied at the end of surgery. The packing may be trimmed or reshaped intraoperatively by the surgeon to fit the cavity.

Locations (3)

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan