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.
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
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Chih-Feng Lin, +886223123456 ext. 65216, drlincf@gmail.com
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 11217
Yun-Ting Chao, +886228757337 ext. 112, yunting001@gmail.com
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
Chia-Hsiang Fu, +88633281200 ext. 8465, fufamily@cgmh.org.tw
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.
- Conditions
- Nasal Surgery, Hemostasis, Nasal Packing
- 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 group | Role | What they receive |
|---|---|---|
| Treatment group (NasoAid) | Experimental | Not described Receives: Device: NasoAid® Intranasal Splint |
| Control group (NasoPore) | Active comparator | Not described Receives: Device: "Stryker" NasoPore Nasal Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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.
- First posted6 Oct 2026
- Study start24 Aug 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nasal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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 28530257Wang 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 24710428Burduk 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 27068885Wang 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 21292198Yan 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 25526585Weber 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 11562881Dabrowska-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 29770875Rettinger G, Kirsche H. Complications in septoplasty. Facial Plast Surg. 2006 Nov;22(4):289-97. doi: 10.1055/s-2006-954847.
PubMed 17131271Ketcham 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 20599092Sommer 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 19221238Liu 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 19414230Valero 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Collagen-Based Absorbable Nasal Packing (NasoAid®) After Nasal Surgery: A Prospective, Single-Blind, Randomized Controlled Multi-Center Trial
- ClinicalTrials.gov ID
- NCT07861061
- Acronym / sponsor ID
- MBI-NSA-202510
- Conditions
- Nasal Surgery, Hemostasis, Nasal Packing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (NasoAid) | Experimental | Device: NasoAid® Intranasal Splint |
| Control group (NasoPore) | Active comparator | Device: "Stryker" NasoPore Nasal Dressing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NasoAid® Intranasal SplintNasoAid® 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 | Treatment group (NasoAid) |
| "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. | Device | Control group (NasoPore) |
Primary outcome
Hemostasis Rate at 24 Hours After Nasal Packing
Time frame: 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.
9 secondary outcomes
Hemostasis Rate at 2, 12, and 48 Hours After Nasal Packing
Time frame: 2 hours, 12 hours, and 48 hours after nasal packing
Endoscopic Nasal Assessment Score
Time frame: Pre-surgery and at Weeks 2, 4, 8, and 12 after surgery
Remnant Nasal Packing Material
Time frame: Week 1 after surgery
Patient-Reported Visual Analog Scale (VAS) of General Assessment
Time frame: Preo-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery
Patient-Reported Visual Analog Scale (VAS) of Product Satisfaction
Time frame: Week 1 after surgery
Sino-Nasal Outcome Test-22 (SNOT-22) Score
Time frame: Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery
Nasal Obstruction Symptom Evaluation (NOSE) Score
Time frame: Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery
Total Nasal Symptom Score (TNSS)
Time frame: Pre-surgery and at Weeks 1, 2, 4, 8, and 12 after surgery
Incidence of Medical Device-Related Adverse Events
Time frame: Day 0 to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 28530257Gamerra 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.
- Results publication: PubMed 24710428Wang 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.
- Results publication: PubMed 27068885Burduk 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.
- Results publication: PubMed 21292198Wang 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.
- Results publication: PubMed 25526585Yan 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.
- Results publication: PubMed 11562881Weber 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.
- Results publication: PubMed 29770875Dabrowska-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.
- Results publication: PubMed 17131271Rettinger G, Kirsche H. Complications in septoplasty. Facial Plast Surg. 2006 Nov;22(4):289-97. doi: 10.1055/s-2006-954847.
- Results publication: PubMed 20599092Ketcham 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.
- Results publication: PubMed 19221238Sommer 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.
- Results publication: PubMed 19414230Liu 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.
- Results publication: PubMed 29345622Valero 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
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.