NCT02687438

Brief Summary

Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

January 26, 2016

Last Update Submit

November 16, 2016

Conditions

Chronic Sinusitis

Keywords

Steroid-eluting implant Mometasone Furoate

Outcome Measures

Primary Outcomes (2)

  • the change from baseline to day 90 in nasal obstruction / congestion score

    nasal obstruction/congestion scored by patients

    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

    baseline and 90 days from surgery

Secondary Outcomes (10)

  • Ethmoid Sinus Obstruction

    Baseline, Day 14, Day 30, Day 90 and Month 6

  • Bilateral Polyp Grading

    Day 14, Day 30, Month 6

  • Adhesion Scarring Score

    Baseline, Day 14, Day 30, Day 90 and Month 6

  • Inflammation Score

    Baseline, Day 14, Day 30, Day 90 and Month 6

  • Coagulum/ Crusting Score

    Baseline, Day 14, Day 30, Day 90 and Month 6

  • +5 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)

Device: Steroid-releasing sinus implantOther: Post-op standard of care

Interventions

Steroid-releasing sinus implantDEVICE

PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days

Also known as: PROPEL
Treatment
Post-op standard of careOTHER

post-op standard of care including debridement, irrigation, and/or topical steroids

Also known as: debridement, irrigation, topical steroids (e.g. mometasone furoate)
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Not able to give consent
  • Oral-steroid dependent condition
  • Allergy or intolerance to corticosteroids
  • Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ENT and Allergy Associates, LLP

Lake Success, New York, 11042, United States

Location

ENT and Allergy Associates, LLP

New York, New York, 10016, United States

Location

ENT and Allergy Associates, LLP

Port Jefferson, New York, 11777, United States

Location

ENT and Allergy Associates, LLP

White Plains, New York, 10601, United States

Location

MeSH Terms

Interventions

DebridementTherapeutic IrrigationSteroids

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeHydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • B.Todd Schaeffer, MD

    ENT and Allergy Associates, LLP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 22, 2016

Study Start

December 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)