Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07560254
NA

Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery

Sponsor: Ayu, Inc.

View on ClinicalTrials.gov

Summary

This clinical trial evaluated two absorbable nasal packing materials - VELNEZ and NASOPORE - in adult patients (18-70 years) who underwent nasal surgery, including septoplasty, FESS, or turbinoplasty. The study addressed two core questions: whether VELNEZ offered superior haemorrhage control and faster biodegradation, and whether it reduced postoperative pain, fibrosis, adhesion, and discomfort compared to NASOPORE. Participants were randomised to receive either packing material following surgery. They were monitored on the day of surgery for haemostasis and device performance, then followed up with clinical and endoscopic assessments - including pain scoring and adverse event tracking - through Day 90.

Official title: A Prospective, Open-Labelled, Single-Center, Two-Arm, Randomized Clinical Study to Compare Patient Satisfaction and Clinical Outcome Associated With Two Nasal Packs (VELNEZ Vs NASOPORE) in Nasal Surgery.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-09-11

Completion Date

2025-07-20

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DEVICE

VELNEZ Nasal Pack

VELNEZ is a biodegradable composite nasal packing material composed of gelatin, chitosan, polyvinyl alcohol, and psyllium husk. It is designed to fragment and degrade within the nasal cavity after app

DEVICE

NASOPORE Nasal Pack

NASOPORE is a biosynthetic biodegradable polyurethane foam nasal packing material. It absorbs fluids, conforms to the nasal cavity, and gradually fragments over time. The device is used for postoperative bleeding control, support of nasal structures, and facilitation of healing following nasal surgery.

Locations (1)

Hospital Al-Sultan Abdullah, Universiti Teknologi MARA, Jalan Hospital, UiTM Sungai Buloh Campus

Sungai Buloh, Selangor, Malaysia