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Chronic SinusitisPhase 3PROGRESSNCT02266810

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

A Phase 3 study testing PROPEL Mini Sinus Implant., Sinus Surgery alone and Propel Nova Sinus Implant in people with Chronic Sinusitis, run by Intersect ENT at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Sinusitis
What is being tested?
PROPEL Mini Sinus Implant., Sinus Surgery alone and Propel Nova Sinus Implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
10 sitesUnited States
Study dates
Sep 2014to Oct 2016
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Albany ENT and Allergy

    Albany, New York, 12206

  • ENT of Georgia

    Atlanta, Georgia, 30342

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40207

  • East Virginia Medical School

    Norfolk, Virginia, 23507

  • The Connecticut Center for Advanced ENT Care

    Norwalk, Connecticut, 06851

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Sacramento Ear, Nose and Throat

    Sacramento, California, 95815

  • Breathe Clear Institute of Sinus and Allergy Relief

    Torrance, California, 90503

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20006

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
PROPEL Mini Sinus Implant., Sinus Surgery alone, Propel Nova Sinus Implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROPEL Mini Sinus Implant.Device

    Placement of sinus implant following frontal sinus surgery

  • Sinus Surgery aloneProcedure or surgery

    Sinus surgery only, without implant placement

  • Propel Nova Sinus ImplantDevice

    Also called PROPEL contour Sinus Implant

    Placement of sinus implant following frontal sinus surgery

Study groups in NCT02266810
Study groupRoleWhat they receive
PROPEL Mini Sinus ImplantExperimentalPropel Mini placed in frontal sinus opening following ESS
Receives: Device: PROPEL Mini Sinus Implant.
Sinus Surgery alone: cohort 1Active comparatorSinus Surgery only: cohort 1: ESS with standard post-operative care.
Receives: Procedure: Sinus Surgery alone
PROPEL Nova Sinus ImplantExperimentalPropel Nova placed in frontal sinus opening following ESS
Receives: Device: Propel Nova Sinus Implant
Sinus Surgery alone: cohort 2Active comparatorSinus Surgery only: cohort 2: ESS with standard post-operative care.
Receives: Procedure: Sinus Surgery alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 30

  2. 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).

    Measured: Day 30

Secondary outcomes (8)

  1. 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).

    Measured: Day 30

  2. 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

    1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)
    2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)
    3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)

    Measured: Day 30

  3. 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.

    Measured: Day 30

  4. 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

    1. Restenosed/Partially Occluded
    2. Occluded

    Measured: Day 30

  5. 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).

    Measured: Day 30

  6. 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

    1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)
    2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)
    3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)

    Measured: Day 30

  7. 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.

    Measured: Day 30

  8. 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

    1. Restenosed/Partially Occluded
    2. Occluded

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionApr 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intra-patient control
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266810
Sponsor's protocol ID
P500-0514
Acronym
PROGRESS
Status last verified
Oct 2017
First submitted
15 Sep 2014
Last updated
15 Aug 2018
Data monitoring committee
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.26140. Epub 2016 Jul 1.

    PubMed 27363723

  • Luong A, Ow RA, Singh A, Weiss RL, Han JK, Gerencer R, Stolovitzky JP, Stambaugh JW, Raman A. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jan;144(1):28-35. doi: 10.1001/jamaoto.2017.1859. Epub 2017 Nov 2.

    PubMed 29098299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PROPEL Mini Sinus Implant., Sinus Surgery alone and Propel Nova Sinus Implant in people with Chronic Sinusitis, run by Intersect ENT at 10 sites 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 8 inclusion and 14 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2017). 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?

Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) (time frame: Day 30). 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?

On the ClinicalTrials.gov record for NCT02266810, which also lists 2 linked publications.

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 15 Aug 2018.

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