Chronic SinusitisNCT02687438
The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
A study testing Steroid-releasing sinus implant in people with Chronic Sinusitis, run by ENT and Allergy Associates, LLP at 4 sites in United States.
Trial summary
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Steroid-releasing sinus implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Confirmed diagnosis of CRS (Chronic Rhinosinusitis) based on the 2015 Clinical Practice Guideline for Adult Sinusitis [6]
- Prior ESS (Ethmoid Sinus Surgery) including bilateral total ethmoidectomy at least 90 days prior to being considered for this study
- Planned ESS includes bilateral polypectomy
- ESS including bilateral polypectomy 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.
- Bilateral polyposis (minimum grade 2 on each side) originating from the ethmoid sinus region
Show all 9Show fewer
- Complaints of at least 2 of the 5 hallmark symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell.
- Minimum symptom threshold (Nasal Obstruction/Congestion minimum score of 2 on scale from 0 to 3)
- Failed medical therapy within the preceding 12 months
Who cannot join
- Not able to give consent
- Oral-steroid dependent condition
- Allergy or intolerance to corticosteroids
- Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ENT and Allergy Associates, LLP
Lake Success, New York, 11042
ENT and Allergy Associates, LLP
New York, New York, 10016
ENT and Allergy Associates, LLP
Port Jefferson, New York, 11777
ENT and Allergy Associates, LLP
White Plains, New York, 10601
About this study
Official title: The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery
Read the detailed description
The PROPEL mometasone furoate-releasing implant (Intersect ENT, Menlo Park, CA) is the first FDA-approved device for reducing the need for post-operative interventions by maintaining patency and delivering steroid medication directly into the ethmoid cavity following surgery. Five recently published clinical trials have demonstrated that the mometasone furoate-releasing implant placed in the hospital operating room or in the office setting produces statistically significant reductions in inflammation, polyp formation, and postoperative adhesions. In addition, the implant has been found to significantly reduce the need for postoperative prescription of oral steroids and to decrease the frequency of postoperative lysis of adhesions. Minimal adverse effects were reported in these trials.
- Conditions
- Chronic Sinusitis
- Being tested
- Steroid-releasing sinus implant, Post-op standard of care
- Keywords
- Steroid-eluting implant Mometasone Furoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid-releasing sinus implantDevice
Also called PROPEL
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
Post-op standard of careOther
Also called debridement, irrigation, topical steroids (e.g. mometasone furoate)
post-op standard of care including debridement, irrigation, and/or topical steroids
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) Receives: Device: Steroid-releasing sinus implant; Other: Post-op standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline to day 90 in nasal obstruction / congestion score
nasal obstruction/congestion scored by patients
Measured: baseline and 90 days from surgery
the change from baseline to day 90 in bilateral polyp grade
clinical investigator assessed and by an independent reviewer based on video-endoscopy review
Measured: baseline and 90 days from surgery
Secondary outcomes (10)
Ethmoid Sinus Obstruction
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Measured: Baseline, Day 14, Day 30, Day 90 and Month 6
Bilateral Polyp Grading
Bilateral polyp grade assessed by clinical investigator and by an independent reviewer based on video-endoscopy review
Measured: Day 14, Day 30, Month 6
Adhesion Scarring Score
assessed by clinical investigators and by an independent reviewer
Measured: Baseline, Day 14, Day 30, Day 90 and Month 6
Inflammation Score
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Measured: Baseline, Day 14, Day 30, Day 90 and Month 6
Coagulum/ Crusting Score
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Measured: Baseline, Day 14, Day 30, Day 90 and Month 6
Nasal Obstruction/ Congestion Score
scored by patients
Measured: Day 14, Day 30, Month 6
Sino-Nasal Outcome Test (SNOT 22)
scored by patients
Measured: Baseline, Day 14, Day 30, Day 90 and Month 6
Medication Requirements
evaluate the need for medication, assessed by clinical investigators
Measured: Month 6 post-surgery versus Month 6 post-baseline
Patient Preference Questionnaire
patient tolerability and satisfaction assessed by clinical investigators
Measured: Baseline procedure, Day 90
Implant Placement Success Rate
successful access to, and placement of PROPEL Sinus Implant to the target site
Measured: time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENT and Allergy Associates, LLP
- Sponsor type
- University, hospital or other
- Collaborators
- Intersect ENT
- Responsible party
- Sponsor
- Investigators
- B.Todd Schaeffer, MD, Principal investigator, ENT and Allergy Associates, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687438
- Sponsor's protocol ID
- PIO III
- Status last verified
- Nov 2016
- First submitted
- 26 Jan 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
- ClinicalTrials.gov ID
- NCT02687438
- Acronym / sponsor ID
- PIO III
- Conditions
- Chronic Sinusitis
- Keywords
- Steroid-eluting implant Mometasone Furoate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ENT and Allergy Associates, LLPUniversity, hospital or other
- Collaborators
- Intersect ENT
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery
Detailed description
The PROPEL mometasone furoate-releasing implant (Intersect ENT, Menlo Park, CA) is the first FDA-approved device for reducing the need for post-operative interventions by maintaining patency and delivering steroid medication directly into the ethmoid cavity following surgery. Five recently published clinical trials have demonstrated that the mometasone furoate-releasing implant placed in the hospital operating room or in the office setting produces statistically significant reductions in inflammation, polyp formation, and postoperative adhesions. In addition, the implant has been found to significantly reduce the need for postoperative prescription of oral steroids and to decrease the frequency of postoperative lysis of adhesions. Minimal adverse effects were reported in these trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Steroid-releasing sinus implant, Other: Post-op standard of careSteroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Confirmed diagnosis of CRS (Chronic Rhinosinusitis) based on the 2015 Clinical Practice Guideline for Adult Sinusitis [6]
- Prior ESS (Ethmoid Sinus Surgery) including bilateral total ethmoidectomy at least 90 days prior to being considered for this study
- Planned ESS includes bilateral polypectomy
- ESS including bilateral polypectomy 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.
Key exclusion criteria (5 listed)
- Not able to give consent
- Oral-steroid dependent condition
- Allergy or intolerance to corticosteroids
- Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
- Pregnancy
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 |
|---|---|---|
| Steroid-releasing sinus implantAlso: PROPELPROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days | Device | Treatment |
| Post-op standard of careAlso: debridement, irrigation, topical steroids (e.g. mometasone furoate)post-op standard of care including debridement, irrigation, and/or topical steroids | Other | Treatment |
Primary outcome
the change from baseline to day 90 in nasal obstruction / congestion score
Time frame: baseline and 90 days from surgery
nasal obstruction/congestion scored by patients
the change from baseline to day 90 in bilateral polyp grade
Time frame: baseline and 90 days from surgery
clinical investigator assessed and by an independent reviewer based on video-endoscopy review
10 secondary outcomes
Ethmoid Sinus Obstruction
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
Bilateral Polyp Grading
Time frame: Day 14, Day 30, Month 6
Adhesion Scarring Score
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
Inflammation Score
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
Coagulum/ Crusting Score
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
Nasal Obstruction/ Congestion Score
Time frame: Day 14, Day 30, Month 6
Sino-Nasal Outcome Test (SNOT 22)
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
Medication Requirements
Time frame: Month 6 post-surgery versus Month 6 post-baseline
Patient Preference Questionnaire
Time frame: Baseline procedure, Day 90
Implant Placement Success Rate
Time frame: time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- 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.
B.Todd Schaeffer, MD principal investigator
ENT and Allergy Associates, LLP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid-releasing sinus implant in people with Chronic Sinusitis, run by ENT and Allergy Associates, LLP at 4 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 9 inclusion and 5 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the change from baseline to day 90 in nasal obstruction / congestion score (time frame: baseline and 90 days from surgery). 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 17 Nov 2016.