Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus

Chronic Sinusitis Clinical Trial

— PROGRESS  

Official title:

The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266810
• Other study ID #: P500-0514
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.

Description:

This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.

• Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery.

• Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure.

• Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of =1 on each side.

• Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created.

• Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)

• Septoplasty for access to the ostio-meatal complex is permitted.

• ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.

Exclusion Criteria:

• Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV)

• Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition

• Known history of allergy or intolerance to corticosteroids or mometasone furoate

• Clinical evidence of acute bacterial sinusitis

• Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)

• Active viral illness

• Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease

• Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period

• Currently participating in another clinical trial

• History of insulin dependent diabetes mellitus

• Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure

• Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea

• Current ESS including frontal sinus surgery is aborted for any reason.

• At least one side is not amenable for implant placement.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• PROPEL Mini Sinus Implant.
Placement of sinus implant following frontal sinus surgery

Procedure:
• Sinus Surgery alone
Sinus surgery only, without implant placement

Device:
• Propel Nova Sinus Implant
Placement of sinus implant following frontal sinus surgery

Locations

Country	Name	City	State
United States	Albany ENT and Allergy	Albany	New York
United States	ENT of Georgia	Atlanta	Georgia
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	East Virginia Medical School	Norfolk	Virginia
United States	The Connecticut Center for Advanced ENT Care	Norwalk	Connecticut
United States	Oregon Health and Science University	Portland	Oregon
United States	Sacramento Ear, Nose and Throat	Sacramento	California
United States	Breathe Clear Institute of Sinus and Allergy Relief	Torrance	California
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Intersect ENT	Advance Research Associates

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.2614 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)	The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.; Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).	Day 30
Primary	Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)	The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.; Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).	Day 30
Secondary	Need for Post-operative Interventions (Propel Mini Cohort)	Need for post-operative interventions by clinical investigators at Day 30; Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).	Day 30
Secondary	Need for Surgical Interventions (Propel Mini Cohort)	Need for Surgical Interventions by clinical investigators at Day 30.; Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.; Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO; Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted); Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted); Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)	Day 30
Secondary	Inflammation (Propel Mini Cohort)	The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.	Day 30
Secondary	Occlusion/Restenosis (Propel Mini Cohort)	Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent; Restenosed/Partially Occluded; Occluded	Day 30
Secondary	Need for Post-operative Interventions (Propel Nova Cohort)	Need for post-operative interventions by clinical investigators at Day 30.; Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).	Day 30
Secondary	Need for Surgical Interventions (Propel Nova Cohort)	Need for Surgical Interventions by clinical investigators at Day 30; Need for Surgical Interventions by clinical investigators at Day 30.; Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.; Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO; Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted); Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted); Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)	Day 30
Secondary	Inflammation (Propel Nova Cohort)	The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.	Day 30
Secondary	Occlusion/Restenosis (Propel Nova Cohort)	Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent; Restenosed/Partially Occluded; Occluded	Day 30