Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-05-26

Brief Summary

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The purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) Propel Implant or 2) Nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ESS) for chronic rhinosinusitis.

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Detailed Description

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1. The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.
2. Nasopore soaked with triamcinolone. This "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.

Both of these procedures are currently used regularly by Dr. Pearlman in practice at the conclusion of ESS for treatment of chronic rhinosinusitis. As standard of care, treatment is determined intraoperatively (during surgery), at the discretion of the surgeon. In this study, each subject will have both treatments (one in each cavity). The 'experimental' aspect relates to directly comparing the two procedures.

This research study is being done because there is currently a lack of consensus regarding the optimal nasal packing regimen. There have been no comparison studies and practice patterns vary widely. Our study looks to compare the Propel implant to Nasopore packing soaked in Triamcinolone.

Conditions

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Chronic Sinusitis Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each subject will have both treatments (Propel and Nasopore), with one treatment on one side and the other treatment on the opposite side. The treatment for the right and left cavity will be selected in a randomized fashion (using opaque envelopes to assign each treatment to a respective ethmoid cavity).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subjects will not have access to what treatment each cavity received through randomization. The information will be available should an emergency arise that would require the treating physician to know this information in order to best treat the subject. The subjects right to access this information will be reinstated when the study period is over (12 weeks after surgery).

Study Groups

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Propel Implant

The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.

Group Type OTHER

Propel 'implant'

Intervention Type DEVICE

The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.

Nasopore soaked with triamcinolone

This "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.

Group Type OTHER

Triamcinolone

Intervention Type DRUG

Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.

Nasopore

Intervention Type DEVICE

This "packing' is a sponge-like material which dissolves while releasing triamcinolone.

Interventions

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Propel 'implant'

The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.

Intervention Type DEVICE

Triamcinolone

Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.

Intervention Type DRUG

Nasopore

This "packing' is a sponge-like material which dissolves while releasing triamcinolone.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

-Adult patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis refractory to medical management

Exclusion Criteria

* Patients ineligible for informed consent
* Patients unwilling or unable to comply with the postoperative visits necessary for data collection
* Patients with a history of intolerance to triamcinolone
* Patients with suspected systemic inflammatory disease, cystic fibrosis, and any contraindication to systemic corticosteroids.
* As standard of care, the PI does not operate on pregnant patients. A pregnant patient would not be a candidate for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No