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Nasal SurgeryNCT07861061

Efficacy and Safety of NasoAid® After Nasal Surgery

A study testing NasoAid® Intranasal Splint and "Stryker" NasoPore Nasal Dressing in people with Nasal Surgery and Hemostasis, run by Maxigen Biotech Inc. at 3 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasal Surgery, Hemostasis, Nasal Packing
What is being tested?
NasoAid® Intranasal Splint and "Stryker" NasoPore Nasal Dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
3 sitesTaiwan
Study dates
24 Aug 2026to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-75 years
  • Patients needing nasal surgery that requires bilateral nasal packing: types of operations include septomeatal plasty. The bilateral packing material will be trimmed to fit the size of the patient's wound or nasal cavity, at the physician's discretion.

Who cannot join

  • Severe anatomical abnormalities of the nasal cavity or sinuses, including trauma related structural changes, congenital craniofacial malformations, skull base defects or cerebrospinal fluid (CSF) leak, septal perforation, or other abnormalities that could interfere with the evaluation of study outcomes or pose a safety risk to the subject, as evaluated by the investigator.
  • Acute sinusitis with abscess formation or severe mucosal swelling.
  • Diagnosed with secondary chronic rhinosinusitis; however, patients with recurrence of the condition requiring additional surgery can be included in the study.
  • Benign or malignant tumors in the nasal cavity or sinuses.
  • Diagnosis of cystic fibrosis, primary ciliary dyskinesia (including Kartagener syndrome), or other conditions associated with impaired mucociliary clearance.
  • Patients with known allergies to collagen.
Show all 14Show fewer
  • Patients receiving systemic corticosteroid therapy within the past 4 weeks, or ongoing corticosteroid treatment for any condition; however, patients using nasal spray therapy are allowed to participate.
  • Coagulation disorders and/or receiving anticoagulant therapy which impact the nasal surgery (e.g., International Normalize Ratio [INR] > 1.5). Patients with coagulation function suitable for surgery (INR ≤ 1.5) are eligible.
  • Uncontrolled chronic disease with risk factor for postoperative hemorrhage such as cardiovascular disease, diabetes mellitus and hypertension, as evaluated by the investigator.
  • Pregnancy or breastfeeding women.
  • Presence of any contraindication to surgical intervention, as evaluated by the investigator.
  • Unable to comply with the follow-up and postoperative care requirements.
  • Any clinically relevant condition, in the investigator's judgment, would interfere with the evaluation of study outcomes or pose a safety risk to the subject.
  • Participation in other interventional trials or studies.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan3 sites, 3 recruiting
  • National Taiwan University Hospital

    Taipei, 100229

    Chih-Feng Lin, +886223123456 ext. 65216, drlincf@gmail.com

    Recruiting
  • Taipei Veterans General Hospital

    Taipei, 11217

    Yun-Ting Chao, +886228757337 ext. 112, yunting001@gmail.com

    Not yet recruiting
  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

    Chia-Hsiang Fu, +88633281200 ext. 8465, fufamily@cgmh.org.tw

    Recruiting

Other trials in Taiwan

About this study

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

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.
Read more

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.

Read the detailed description

This study is conducted as a randomized, single-blind, multicenter, non-inferiority clinical trial to compare the use of two different nasal packing material, synthetic (NasoPore) versus collagen-based (NasoAid) in patients undergoing nasal surgery requiring nasal packing. Nasal packing material acts as an intranasal splint to minimize bleeding in nasal cavity or septum. Hemostasis will be assessed at 2, 12, 24 and 48 hours after surgery. Subjects will be followed for 12 weeks. Remnant percentage of nasal packing material will be evaluated at Weeks 1 after surgery. Endoscopic nasal assessments will be performed at Week 2, 4, 8, and 12 after surgery to evaluate nasal conditions. Patient-reported outcomes, including visual analog scales (VAS), Sino-Nasal Outcome Test-22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE score), and Total Nasal Symptom Score (TNSS), will be assessed before surgery and at Week 1, 2, 4, 8, and 12 after surgery. Safety data and adverse events would be recorded throughout the study.

Being tested
NasoAid® Intranasal Splint, "Stryker" NasoPore Nasal Dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NasoAid® Intranasal SplintDevice

    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.

  • "Stryker" NasoPore Nasal DressingDevice

    "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.

Study groups in NCT07861061
Study groupRoleWhat they receive
Treatment group (NasoAid)ExperimentalNot described
Receives: Device: NasoAid® Intranasal Splint
Control group (NasoPore)Active comparatorNot described
Receives: Device: "Stryker" NasoPore Nasal Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemostasis Rate at 24 Hours After Nasal Packing

    Hemostasis will be assessed using a four-grade bleeding scale: 0 = no bleeding; 1 = minimal bleeding confined to the nasal cavity; 2 = moderate bleeding extending outside the nasal cavity without requiring repacking; and 3 = severe bleeding requiring repacking. The hemostasis rate will be compared between the NasoAid and NasoPore groups.

    Measured: 24 hours after nasal packing

Secondary outcomes (9)
  1. Hemostasis Rate at 2, 12, and 48 Hours After Nasal Packing

    Hemostasis will be assessed using the same four-grade bleeding scale as the primary outcome: 0 = no bleeding; 1 = minimal bleeding confined to the nasal cavity; 2 = moderate bleeding extending outside the nasal cavity without requiring repacking; and 3 = severe bleeding requiring repacking. The hemostasis rates will be compared between the NasoAid and NasoPore groups.

    Measured: 2 hours, 12 hours, and 48 hours after nasal packing

  2. Endoscopic Nasal Assessment Score

    Endoscopic nasal assessment will evaluate four parameters: edema, discharge, scarring, and crusting. Each parameter is scored from 0 to 2, with higher scores indicating greater severity. The score for each side of the nasal cavity ranges from 0 to 8, resulting in a total score ranging from 0 to 16. Scores will be compared between the NasoAid and NasoPore groups.

    Measured: Pre-surgery and at Weeks 2, 4, 8, and 12 after surgery

  3. Remnant Nasal Packing Material

    The amount of remnant nasal packing material in the middle meatus of each side will be assessed by nasal endoscopy before suction or removal. The remaining amount is graded as 0 = none, 1 = 25%, 2 = 25-50%, 3 = 50-75%, and 4 = greater than 75%. The ease of removing the nasal packing by suction or forceps will also be evaluated using a 0-to-10 scale, with 0 indicating very easy and 10 indicating extremely difficult.

    Measured: Week 1 after surgery

  4. Patient-Reported Visual Analog Scale (VAS) of General Assessment

    Subjects will rate four aspects of their postoperative condition using 0-to-10 visual analog scales: severity of nasal symptoms, discomfort caused by nasal symptoms, discomfort caused by olfactory abnormalities, and the impact of nasal symptoms on sleep. Higher scores indicate greater symptom severity, discomfort, or impact.

    Measured: Preo-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery

  5. Patient-Reported Visual Analog Scale (VAS) of Product Satisfaction

    Subjects will assess their experience with the nasal packing using three 0-to-10 visual analog scales: pain caused by the nasal packing during packing, nasal breathing obstruction caused by the packing, and pain during removal of the nasal packing. Higher scores indicate greater pain or obstruction.

    Measured: Week 1 after surgery

  6. Sino-Nasal Outcome Test-22 (SNOT-22) Score

    The SNOT-22 consists of 22 patient-reported items assessing sinonasal symptoms and related social and emotional impacts. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be), resulting in a total score ranging from 0 to 110.

    Measured: Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery

  7. Nasal Obstruction Symptom Evaluation (NOSE) Score

    The NOSE scale consists of five patient-reported items related to nasal obstruction. Each item is scored from 0 (not a problem) to 4 (severe problem). The sum of the five item scores is multiplied by 5 to obtain a total score ranging from 0 to 100. Higher scores indicate greater severity of nasal obstruction.

    Measured: Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery

  8. Total Nasal Symptom Score (TNSS)

    The TNSS is a patient-reported assessment of four nasal symptoms: nasal congestion, nasal itching, sneezing, and runny nose. Each symptom is scored from 0 (no symptoms) to 3 (severe), resulting in a total score ranging from 0 to 12. Higher scores indicate greater nasal symptom severity.

    Measured: Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery

  9. Incidence of Medical Device-Related Adverse Events

    The incidence will be calculated to represent the percentage of patients who experience medical device-related adverse and compared between the NasoAid and NasoPore groups.

    Measured: Day 0 to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start24 Aug 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07861061
Sponsor's protocol ID
MBI-NSA-202510
Status last verified
Sep 2026
First submitted
30 Sep 2026
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gamerra M, Cantone E, Sorrentino G, De Luca R, Russo MB, De Corso E, Bossa F, De Vivo A, Iengo M. Mathematical model for preoperative identification of obstructed nasal subsites. Acta Otorhinolaryngol Ital. 2017 Oct;37(5):410-415. doi: 10.14639/0392-100X-1385.

    PubMed 28530257
  • Wang J, Cai C, Wang S. Merocel versus Nasopore for nasal packing: a meta-analysis of randomized controlled trials. PLoS One. 2014 Apr 7;9(4):e93959. doi: 10.1371/journal.pone.0093959. eCollection 2014.

    PubMed 24710428
  • Burduk PK, Wierzchowska M, Grzeskowiak B, Kazmierczak W, Wawrzyniak K. Clinical outcome and patient satisfaction using biodegradable (NasoPore) and non-biodegradable packing, a double-blind, prospective, randomized study. Braz J Otorhinolaryngol. 2017 Jan-Feb;83(1):23-28. doi: 10.1016/j.bjorl.2016.01.001. Epub 2016 Mar 28.

    PubMed 27068885
  • Wang YP, Wang MC, Chen YC, Leu YS, Lin HC, Lee KS. The effects of Vaseline gauze strip, Merocel, and Nasopore on the formation of synechiae and excessive granulation tissue in the middle meatus and the incidence of major postoperative bleeding after endoscopic sinus surgery. J Chin Med Assoc. 2011 Jan;74(1):16-21. doi: 10.1016/j.jcma.2010.09.001.

    PubMed 21292198
  • Yan M, Zheng D, Li Y, Zheng Q, Chen J, Yang B. Biodegradable nasal packings for endoscopic sinonasal surgery: a systematic review and meta-analysis. PLoS One. 2014 Dec 19;9(12):e115458. doi: 10.1371/journal.pone.0115458. eCollection 2014.

    PubMed 25526585
  • Weber R, Keerl R, Hochapfel F, Draf W, Toffel PH. Packing in endonasal surgery. Am J Otolaryngol. 2001 Sep-Oct;22(5):306-20. doi: 10.1053/ajot.2001.26499.

    PubMed 11562881
  • Dabrowska-Bien J, Skarzynski PH, Gwizdalska I, Lazecka K, Skarzynski H. Complications in septoplasty based on a large group of 5639 patients. Eur Arch Otorhinolaryngol. 2018 Jul;275(7):1789-1794. doi: 10.1007/s00405-018-4990-8. Epub 2018 May 16.

    PubMed 29770875
  • Rettinger G, Kirsche H. Complications in septoplasty. Facial Plast Surg. 2006 Nov;22(4):289-97. doi: 10.1055/s-2006-954847.

    PubMed 17131271
  • Ketcham AS, Han JK. Complications and management of septoplasty. Otolaryngol Clin North Am. 2010 Aug;43(4):897-904. doi: 10.1016/j.otc.2010.04.013.

    PubMed 20599092
  • Sommer M, Geurts JW, Stessel B, Kessels AG, Peters ML, Patijn J, van Kleef M, Kremer B, Marcus MA. Prevalence and predictors of postoperative pain after ear, nose, and throat surgery. Arch Otolaryngol Head Neck Surg. 2009 Feb;135(2):124-30. doi: 10.1001/archoto.2009.3.

    PubMed 19221238
  • Liu CY, Yu EC, Lin SH, Wang YP, Wang MC. Learning curve of septomeatoplasty. Auris Nasus Larynx. 2009 Dec;36(6):661-4. doi: 10.1016/j.anl.2009.03.005. Epub 2009 May 2.

    PubMed 19414230
  • Valero A, Navarro AM, Del Cuvillo A, Alobid I, Benito JR, Colas C, de Los Santos G, Fernandez Liesa R, Garcia-Lliberos A, Gonzalez-Perez R, Izquierdo-Dominguez A, Jurado-Ramos A, Lluch-Bernal MM, Montserrat Gili JR, Mullol J, Puiggros Casas A, Sanchez-Hernandez MC, Vega F, Villacampa JM, Armengot-Carceller M, Dordal MT; SEAIC Rhinoconjunctivitis Committee & SEORL Rhinology, Allergy, and Skull Base Committee. Position paper on nasal obstruction: evaluation and treatment. J Investig Allergol Clin Immunol. 2018;28(2):67-90. doi: 10.18176/jiaci.0232. Epub 2018 Jan 18.

    PubMed 29345622

Questions about this trial

What is this clinical trial studying?

A study testing NasoAid® Intranasal Splint and "Stryker" NasoPore Nasal Dressing in people with Nasal Surgery and Hemostasis, run by Maxigen Biotech Inc. at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact LiRong Chen (+88633287222 ext. 1250, lirong.chen@mbi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemostasis Rate at 24 Hours After Nasal Packing (time frame: 24 hours after nasal packing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07861061, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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