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

NCT ID: NCT03599271

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2020-12-09

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)

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug-Coated Device

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

Group Type: EXPERIMENTAL

Drug-Coated Device

Intervention Type: DEVICE

3000 mcg mometasone furoate-coated sinus dilation device

Control Sinus Dilation Device

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

Group Type: ACTIVE_COMPARATOR

Control Device

Intervention Type: DEVICE

Sinus dilation device without drug

PK cohort- Drug-Coated Device

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

Group Type: EXPERIMENTAL

Drug-Coated Device

Intervention Type: DEVICE

3000 mcg mometasone furoate-coated sinus dilation device

Interventions

Drug-Coated Device

3000 mcg mometasone furoate-coated sinus dilation device

Intervention Type: DEVICE

Control Device

Sinus dilation device without drug

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Confirmed diagnosis of CRS per the 2016, "International Consensus Statement on Allergy and Rhinology" definition.

2. 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.

3. 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).

4. Balloon dilation of the FSO judged to be feasible and medically appropriate.

5. 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.

6. 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.

Exclusion Criteria

1. Expanded amount of ethmoid polyposis (grade > 2 PK cohort, grade ≥ 2 randomized cohort).

2. Complications from prior ESS or balloon dilation procedure (e.g., cerebrospinal fluid leak or injury to the skull base).

3. History of aspirin exacerbated respiratory disease (AERD).

4. Current smokers.

5. History of allergy or intolerance to mometasone furoate.

6. Oral-steroid dependent condition.

7. 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.

8. Use of parenteral and injected steroids (e.g., Kenalog) 30 days prior to the baseline procedure.

9. 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.

10. Glaucoma or posterior subcapsular cataract.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intersect ENT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centers for Advanced ENT Care

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P500-0118

Identifier Type: -

Identifier Source: org_study_id