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The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery

NCT02687438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-11-17

No results posted yet for this study

Summary

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

Conditions

  • Chronic Sinusitis

Interventions

DEVICE

Steroid-releasing sinus implant

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

OTHER

Post-op standard of care

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

Sponsors & Collaborators

  • Intersect ENT

    collaborator INDUSTRY

  • ENT and Allergy Associates, LLP

    lead OTHER

Principal Investigators

  • B.Todd Schaeffer, MD · ENT and Allergy Associates, LLP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687438 on ClinicalTrials.gov