Chronic Rhinosinusitis
Conditions
Brief 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).
Interventions
DEVICEElectromagnetic 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.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years of age. 2. Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery. 3. Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia. 4. 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. 5. Subject is willing and able to comply with protocol requirements.
Exclusion criteria
1. Subject is pregnant or breastfeeding. 2. Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator. 3. Subject has sinonasal tumors. 4. 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. 5. Subject lacks capacity to consent to participation in this research himself/herself.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Safety Profile as Measured by the Overall Adverse Event Rate | 2 weeks | Overall adverse event rate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NuVent™ Revision patients treated with NuVent™
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. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawn prior to treatment | 1 |
Baseline characteristics
| Characteristic | NuVent™ |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 14.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
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.
Time frame: 2 weeks
Population: Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NuVent™ | Device-related Adverse Event Point Estimate | 0 Adverse Events |
Primary
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
Time frame: At time of surgery
Population: All patients that completed the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NuVent™ | Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium | 121 Number of sinuses |
Secondary
Device Safety Profile as Measured by the Overall Adverse Event Rate
Overall adverse event rate
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NuVent™ | Device Safety Profile as Measured by the Overall Adverse Event Rate | 18 Percentage of participants with an AE |