A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND)

NCT03599271 | Completed Results

• 1 other identifier: P500-0118
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Baseline

Secondary Outcomes (4)

• Randomized Cohort: Estimated Frontal Sinus Ostia (FSO) Diameter

  30 days

• PK Cohort: Estimated Largest Frontal Sinus Ostia (FSO) Diameter

  Baseline to 30 days

• PK Cohort: Estimated Smallest Frontal Sinus Ostia (FSO) Diameter

  Baseline to 30 days

• PK Cohort: Total Sino-Nasal Outcomes Test Score (SNOT-22)

  Baseline, Day 14 and Day 30

Study Arms (3)

Drug-Coated Device

EXPERIMENTAL

Randomized cohort: Drug-Coated Device to dilate randomized frontal sinus ostium.

Device: Drug-Coated Device

Control Sinus Dilation Device

ACTIVE COMPARATOR

Randomized cohort: Control Device to dilate randomized contralateral frontal sinus ostium.

Device: Control Device

PK cohort- Drug-Coated Device

EXPERIMENTAL

PK cohort: One Drug-Coated Device to dilate both frontal sinus ostia.

Device: Drug-Coated Device

Interventions

Drug-Coated Device DEVICE

3000 mcg mometasone furoate-coated sinus dilation device

Drug-Coated Device; PK cohort- Drug-Coated Device

Control Device DEVICE

Sinus dilation device without drug

Control Sinus Dilation Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (1)

Centers for Advanced ENT Care

Baltimore, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andrew Campbell PhD, MPH Clinical Affairs Director
• Organization: Intersect ENT

acampbell@intersectent.com

6506412100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The randomized cohort is double-blinded, which both participants and outcome assessor being masked to treatment assignment
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A PK non-randomized cohort in 5 participants, followed by a randomized, intra-patient controlled double-blind cohort in 70 participants

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 26, 2018
• Study Start: June 12, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 9, 2020
• Last Updated: May 26, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)