Chronic Rhinosinusitis (Diagnosis)NCT03599271
A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)
A study testing Drug-Coated Device in people with Chronic Rhinosinusitis (Diagnosis), run by Intersect ENT at 1 site in United States.
Trial summary
The objective of the ASCEND Study is to assess the safety, performance, and efficacy of the Intersect ENT UP Drug-Coated Device when used in chronic rhinosinusitis (CRS) patients undergoing balloon dilation of frontal sinus ostia (FSO) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Drug-Coated Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 9 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CRS per the 2016, "International Consensus Statement on Allergy and Rhinology" definition.
- Bilateral disease in the frontal sinuses (Lund-Mackay score ≥ 1 on each side) on CT scan within 30 days prior to enrollment in the PK cohort and prior to randomization in the randomized cohort.
- Patient has bilateral obstruction of the frontal recess/FSO due to scarring and/or polypoid edema confirmed on endoscopy (patency grade of 0 or 1 for each FSO).
- Balloon dilation of the FSO judged to be feasible and medically appropriate.
- Patient has had prior ESS (> 30 days with a healed mucosa) including bilateral ethmoidectomy (anterior or total) and uncinectomy for better visualization of the FSO.
- Balloon dilation of the FSO with a 6 mm balloon is judged to be feasible (use light-assisted or image-guided instrument such as a frontal sinus seeker tip to confirm access of each FSO) and medically appropriate.
Who cannot join
- Expanded amount of ethmoid polyposis (grade > 2 PK cohort, grade ≥ 2 randomized cohort).
- Complications from prior ESS or balloon dilation procedure (e.g., cerebrospinal fluid leak or injury to the skull base).
- History of aspirin exacerbated respiratory disease (AERD).
- Current smokers.
- History of allergy or intolerance to mometasone furoate.
- Oral-steroid dependent condition.
Show all 10Show fewer
- Evidence of acute rhinosinusitis, invasive fungal sinusitis or another disease or condition expected to compromise survival or ability to complete assessments during the 30-day follow-up period in the PK cohort and druing the 60-day follow-up period in the randomized cohort.
- Use of parenteral and injected steroids (e.g., Kenalog) 30 days prior to the baseline procedure.
- Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to screening in the PK cohort and prior to baseline in the randomized cohort.
- Glaucoma or posterior subcapsular cataract.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Advanced ENT Care
Baltimore, Maryland, 21204
About this study
Official title: The ASCEND Study: A Clinical Evaluation of the UP Drug-Coated Device in Patients With Chronic Rhinosinusitis
The objective of the ASCEND Study is to assess the safety, performance, and efficacy of the Intersect ENT UP Drug-Coated Device when used in chronic rhinosinusitis (CRS) patients undergoing balloon dilation of frontal sinus ostia (FSO)
Read the detailed description
This is a prospective, multicenter study enrolling two consecutive cohorts:
PK cohort (N=5): A non-randomized cohort to assess the systemic safety and performance of the UP Drug-Coated Device for in-office bilateral dilation of the FSO (2 inflations in each FSO for a total of 4 inflations per device). Subsequently, the UP Drug-Coated Device may be used to dilate any sphenoid or maxillary sinuses.
Randomized cohort (N=70): A randomized, intra-patient controlled, double-blind cohort of 70 subjects to assess the safety and efficacy of the UP Drug-Coated Device used for in-office dilation of the FSO. The FSO randomized to the treatment (Treatment) will undergo dilation using the UP Drug-Coated Device (2 inflations per device) while the contralateral FSO (Control) will be dilated with a UP Control Device (2 inflations per device).
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Drug-Coated Device, Control Device
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated DeviceDevice
3000 mcg mometasone furoate-coated sinus dilation device
Control DeviceDevice
Sinus dilation device without drug
| Study group | Role | What they receive |
|---|---|---|
| Drug-Coated Device | Experimental | Randomized cohort: Drug-Coated Device to dilate randomized frontal sinus ostium. Receives: Device: Drug-Coated Device |
| Control Sinus Dilation Device | Active comparator | Randomized cohort: Control Device to dilate randomized contralateral frontal sinus ostium. Receives: Device: Control Device |
| PK cohort- Drug-Coated Device | Experimental | PK cohort: One Drug-Coated Device to dilate both frontal sinus ostia. Receives: Device: Drug-Coated Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomized Cohort: Difference in Patency Grade of FSO
Difference in the patency grade of the FSO between treatment sides at Day 30, as determined by an independent, blinded sinus surgeon based on the centralized video-endoscopy review. Patency of the FSO assessed endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip ("suction tip") and graded on a 5-point scale as follows - 0: Occluded (no opening visible); 1: Significantly stenosed (not occluded, but unable to pass the 3-mm suction tip); 2: Moderately stenosed (able to easily pass the 3-mm suction tip with no additional space around it); 3: Minimally stenosed (able to easily pass the 3-mm suction tip with additional 1-2 mm space around it); 4: Completely patent (able to easily pass the 3-mm suction tip with additional >2 mm space around it)
Measured: 30 days
The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at Baseline
Successful dilation of attempted FSO using the Drug-Coated Device with no unanticipated serious adverse device effects. A successful dilation of the FSO is defined as insertion of the UP Drug-Coated Device into the targeted FSO followed by 2 consecutive, complete inflations of the balloon.
Measured: Baseline
Secondary outcomes (4)
Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter
The smallest and largest diameters of the FSO determined by an independent, blinded sinus surgeon based on the centralized video-endoscopy review. FSO diameter estimated endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip and reported in mm.
Measured: 30 days
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter
The smallest and largest diameters of the FSO are estimated endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip and reported in mm.
Measured: Baseline to 30 days
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter
The smallest and largest diameters of the FSO are estimated endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip and reported in mm.
Measured: Baseline to 30 days
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22)
SNOT-22 is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by patient on a 6-point scale as follows: 0: No problem; 1: Very mild problem; 2: Mild or slight problem; 3: Moderate problem; 4: Severe problem; 5: Problem as bad as it can be.
Sum of all 22 questions constitutes the total SNOT-22 score with a maximum total score equal to 110.
Measured: Baseline, Day 14 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start12 Jun 2018
- Primary completion15 Dec 2019
- Study completion9 Dec 2020
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 Rhinosinusitis (Diagnosis)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A PK non-randomized cohort in 5 participants, followed by a randomized, intra-patient controlled double-blind cohort in 70 participants
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599271
- Sponsor's protocol ID
- P500-0118
- Status last verified
- May 2021
- First submitted
- 25 Jun 2018
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ASCEND Study: A Clinical Evaluation of the UP Drug-Coated Device in Patients With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT03599271
- Acronym / sponsor ID
- P500-0118
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the ASCEND Study is to assess the safety, performance, and efficacy of the Intersect ENT UP Drug-Coated Device when used in chronic rhinosinusitis (CRS) patients undergoing balloon dilation of frontal sinus ostia (FSO)
Detailed description
This is a prospective, multicenter study enrolling two consecutive cohorts:
PK cohort (N=5): A non-randomized cohort to assess the systemic safety and performance of the UP Drug-Coated Device for in-office bilateral dilation of the FSO (2 inflations in each FSO for a total of 4 inflations per device). Subsequently, the UP Drug-Coated Device may be used to dilate any sphenoid or maxillary sinuses.
Randomized cohort (N=70): A randomized, intra-patient controlled, double-blind cohort of 70 subjects to assess the safety and efficacy of the UP Drug-Coated Device used for in-office dilation of the FSO. The FSO randomized to the treatment (Treatment) will undergo dilation using the UP Drug-Coated Device (2 inflations per device) while the contralateral FSO (Control) will be dilated with a UP Control Device (2 inflations per device).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A PK non-randomized cohort in 5 participants, followed by a randomized, intra-patient controlled double-blind cohort in 70 participants
| Arm | Type | Receives |
|---|---|---|
| Drug-Coated Device | Experimental | Device: Drug-Coated DeviceRandomized cohort: Drug-Coated Device to dilate randomized frontal sinus ostium. |
| Control Sinus Dilation Device | Active comparator | Device: Control DeviceRandomized cohort: Control Device to dilate randomized contralateral frontal sinus ostium. |
| PK cohort- Drug-Coated Device | Experimental | Device: Drug-Coated DevicePK cohort: One Drug-Coated Device to dilate both frontal sinus ostia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of CRS per the 2016, "International Consensus Statement on Allergy and Rhinology" definition.
- Bilateral disease in the frontal sinuses (Lund-Mackay score ≥ 1 on each side) on CT scan within 30 days prior to enrollment in the PK cohort and prior to randomization in the randomized cohort.
- Patient has bilateral obstruction of the frontal recess/FSO due to scarring and/or polypoid edema confirmed on endoscopy (patency grade of 0 or 1 for each FSO).
- Balloon dilation of the FSO judged to be feasible and medically appropriate.
- Patient has had prior ESS (> 30 days with a healed mucosa) including bilateral ethmoidectomy (anterior or total) and uncinectomy for better visualization of the FSO.
Key exclusion criteria (10 listed)
- Expanded amount of ethmoid polyposis (grade > 2 PK cohort, grade ≥ 2 randomized cohort).
- Complications from prior ESS or balloon dilation procedure (e.g., cerebrospinal fluid leak or injury to the skull base).
- History of aspirin exacerbated respiratory disease (AERD).
- Current smokers.
- History of allergy or intolerance to mometasone furoate.
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 |
|---|---|---|
| Drug-Coated Device3000 mcg mometasone furoate-coated sinus dilation device | Device | Drug-Coated Device, PK cohort- Drug-Coated Device |
| Control DeviceSinus dilation device without drug | Device | Control Sinus Dilation Device |
Primary outcome
Randomized Cohort: Difference in Patency Grade of FSO
Time frame: 30 days
Difference in the patency grade of the FSO between treatment sides at Day 30, as determined by an independent, blinded sinus surgeon based on the centralized video-endoscopy review. Patency of the FSO assessed endoscopically by probing with a 3-mm olive-shaped frontal sinus suction tip ("suction tip") and graded on a 5-point scale as follows - 0: Occluded (no opening visible); 1: Significantly stenosed (not occluded, but unable to pass the 3-mm suction tip); 2: Moderately stenosed (able to easily pass the 3-mm suction tip with no additional space around it); 3: Minimally stenosed (able to easily pass the 3-mm suction tip with additional 1-2 mm space around it); 4: Completely patent (able to easily pass the 3-mm suction tip with additional >2 mm space around it)
The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at Baseline
Time frame: Baseline
Successful dilation of attempted FSO using the Drug-Coated Device with no unanticipated serious adverse device effects. A successful dilation of the FSO is defined as insertion of the UP Drug-Coated Device into the targeted FSO followed by 2 consecutive, complete inflations of the balloon.
4 secondary outcomes
Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter
Time frame: 30 days
PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter
Time frame: Baseline to 30 days
PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter
Time frame: Baseline to 30 days
PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22)
Time frame: Baseline, Day 14 and Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- 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.
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 Drug-Coated Device in people with Chronic Rhinosinusitis (Diagnosis), run by Intersect ENT 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 6 inclusion and 10 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 26 May 2021. 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 28 Apr 2021). 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?
Randomized Cohort: Difference in Patency Grade of FSO (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 26 May 2021.