Nasal Airway ObstructionNovapakNCT05747014
Novapak Prospective Observational Clinical Trial
An observational study of Nasal Airway Obstruction, run by Medtronic Surgical Technologies at 4 sites in 2 countries.
Trial summary
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Airway Obstruction
- What is being tested?
- Novapak Nasal Sinus Packing and Stent
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Mar 2023to 13 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from the practices and clinics of the participating Study Investigators or from other non-investigator Otolaryngologist or Rhinologist physician referrals. Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent.
Who may be able to join
- Subject is at least 18 years of age.
- Subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., Novapak).
- After being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent.
- Mentally stable and able to follow the instructions for self-assessment/questionnaire completion.
Who cannot join
- Subject has a shellfish allergy.
- Subject has known bleeding disorder or prescribed anticoagulants.
- Subject has craniofacial abnormalities that may interfere with access to the sinuses.
- Subject is immunocompromised (e.g., taking immunosuppressive medication).
- Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
ENT Associates of South Florida
Boca Raton, Florida, 33487
University of Miami
Miami, Florida, 33136
University of South Florida
Tampa, Florida, 33612
About this study
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.
Read the detailed description
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by:
- Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval
- Collecting all AEs and calculating an overall rate and safety profile for the device
The secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.
- Conditions
- Nasal Airway Obstruction
- Being tested
- Novapak Nasal Sinus Packing and Stent
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novapak Nasal Sinus Packing and StentDevice
Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations.
| Study group | Role | What they receive |
|---|---|---|
| Novapak Subjects | Subjects that are enrolled in the Novapak Study. Receives: Device: Novapak Nasal Sinus Packing and Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment - Adverse Events Related to Device
Outcome Measure #1 for the Primary Outcome is the total number of Adverse Events that are directly attributed to the device and/or those that cannot be determined.
Measured: 30 days
Safety Assessment - All Adverse Events
Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.
Measured: 30 days
Secondary outcomes (5)
Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment
Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions observed by endoscopic examination from procedure through 1-month post treatment.
Measured: 30 days
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment
Outcome Measure #4 for the Secondary Outcome Measures is the graded percentage of vertical height of the middle turbinate taken up by the adhesion using an ordinal scale (0-3), where '0' is No Adhesion Present, and '3' is >50% of middle turbinate height. This scoring is the Valentine method, and participants are graded based on their endoscopic examination.
Measured: 30 days
Effectiveness Assessment - Bleeding Control
Outcome Measure #5 for the Secondary Outcome Measures is to measure control of bleeding by comparing Boezaart Surgical Field Grading Scale scores post operatively, prior to Novapak insertion and post Novapak insertion. The Boezaart scale grades bleeding from Grade 0: No Bleeding through Grade 5: Severe Bleeding.
Measured: 1 day
Effectiveness Assessment - Healing
Outcome Measure #6 for the Secondary Outcome Measures is to measure healing by comparing Lund-Kennedy scores before surgery and at 2 weeks and 1-month post treatment. The Lund-Kennedy Scoring minimum is 0 and maximum is 10, with higher scores indicating worse observed disease. The Lund-Kennedy grading system is as follows:
Nasal Polyps 0 = none; 1 = confined to middle meatus; 2 = beyond middle meatus Discharge 0 = none; 1 = clear and thin; 2 = thick and purulent Edema 0 = absent; 1 = mild; 2 = severe Scarring 0 = absent; 1 = mild; 2 = severe Crusting 0 = absent; 1 = mild; 2 = severe Numerical values for each term are summed for each sinus analyzed; and mean averages are reported.
Measured: 30 day
Effectiveness Assessment - Health Assessment
Outcome Measure #7 for the Secondary Outcome Measures is to measure health by comparing subject scores from the SNOT-22 questionnaire before surgery and at 2 weeks and 1-month post treatment. The Sino-Nasal Outcome Test (SNOT-22) is a validated questionnaire used to assess the severity of 22 symptoms related to the nasal sinuses using a 0-5-point scale (0 = No problem; 1 = Very mild problem; 2 = Mild or slight problem; 4 = Moderate problem; 5 = Problem as bad as it can be). Minimum score: 0; Maximum score: 110. The higher the score the worse the problems are.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start9 Mar 2023
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal Airway ObstructionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen R McKenzie, MS, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747014
- Sponsor's protocol ID
- MDT 22031
- Acronym
- Novapak
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2023
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novapak Prospective Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT05747014
- Acronym / sponsor ID
- Novapak / MDT 22031
- Conditions
- Nasal Airway Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.
Detailed description
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by:
- Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval
- Collecting all AEs and calculating an overall rate and safety profile for the device
The secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novapak Subjects | – | Device: Novapak Nasal Sinus Packing and StentSubjects that are enrolled in the Novapak Study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the practices and clinics of the participating Study Investigators or from other non-investigator Otolaryngologist or Rhinologist physician referrals. Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent.
Key inclusion criteria (4 listed)
- Subject is at least 18 years of age.
- Subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., Novapak).
- After being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent.
- Mentally stable and able to follow the instructions for self-assessment/questionnaire completion.
Key exclusion criteria (5 listed)
- Subject has a shellfish allergy.
- Subject has known bleeding disorder or prescribed anticoagulants.
- Subject has craniofacial abnormalities that may interfere with access to the sinuses.
- Subject is immunocompromised (e.g., taking immunosuppressive medication).
- Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
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 |
|---|---|---|
| Novapak Nasal Sinus Packing and StentPotential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations. | Device | Novapak Subjects |
Primary outcome
Safety Assessment - Adverse Events Related to Device
Time frame: 30 days
Outcome Measure #1 for the Primary Outcome is the total number of Adverse Events that are directly attributed to the device and/or those that cannot be determined.
Safety Assessment - All Adverse Events
Time frame: 30 days
Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.
5 secondary outcomes
Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment
Time frame: 30 days
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment
Time frame: 30 days
Effectiveness Assessment - Bleeding Control
Time frame: 1 day
Effectiveness Assessment - Healing
Time frame: 30 day
Effectiveness Assessment - Health Assessment
Time frame: 30 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Karen R McKenzie, MS study director
Medtronic
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Airway Obstruction, run by Medtronic Surgical Technologies at 4 sites in 2 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment - Adverse Events Related to Device (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.