Chronic RhinosinusitisNCT02284347
NuVent™ Revision Study
A study testing Electromagnetic Sinus Dilation System (NuVent™) in people with Chronic Rhinosinusitis, run by Medtronic Surgical Technologies at 1 site in United States.
Trial summary
This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Electromagnetic Sinus Dilation System (NuVent™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to May 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age.
- Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
- Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
- Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator.
- Subject is willing and able to comply with protocol requirements.
Who cannot join
- Subject is pregnant or breastfeeding.
- Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
- Subject has sinonasal tumors.
- 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.
- Subject lacks capacity to consent to participation in this research himself/herself.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Electromagnetic Sinus Dilation System (NuVent™)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Sinus Dilation System (NuVent™)Device
NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia.
| Study group | Role | What they receive |
|---|---|---|
| NuVent™ | Experimental | Revision patients treated with NuVent™ Receives: Device: Electromagnetic Sinus Dilation System (NuVent™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium
Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium
Measured: At time of surgery
Device-related Adverse Event Point Estimate
The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.
Measured: 2 weeks
Secondary outcomes (1)
Device Safety Profile as Measured by the Overall Adverse Event Rate
Overall adverse event rate
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
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 Chronic RhinosinusitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284347
- Sponsor's protocol ID
- TD-09330
- Status last verified
- Jul 2016
- First submitted
- 28 Oct 2014
- Last updated
- 24 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NuVent™ Revision Study
- ClinicalTrials.gov ID
- NCT02284347
- Acronym / sponsor ID
- TD-09330
- Conditions
- Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NuVent™ | Experimental | Device: Electromagnetic Sinus Dilation System (NuVent™)Revision patients treated with NuVent™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is at least 18 years of age.
- Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
- Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
- Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator.
- Subject is willing and able to comply with protocol requirements.
Key exclusion criteria (5 listed)
- Subject is pregnant or breastfeeding.
- Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
- Subject has sinonasal tumors.
- 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.
- Subject lacks capacity to consent to participation in this research himself/herself.
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 |
|---|---|---|
| Electromagnetic Sinus Dilation System (NuVent™)NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia. | Device | NuVent™ |
Primary outcome
Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium
Time frame: At time of surgery
Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium
Device-related Adverse Event Point Estimate
Time frame: 2 weeks
The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.
1 secondary outcome
Device Safety Profile as Measured by the Overall Adverse Event Rate
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Sinus Dilation System (NuVent™) in people with Chronic Rhinosinusitis, run by Medtronic Surgical Technologies at 1 site in United States.
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 5 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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 24 Aug 2016). 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?
Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium (time frame: At time of surgery). 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 24 Aug 2016.