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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Sinusitis; Rhinosinusitis
• Intervention / Treatment: Device: Propel 'implant'; Drug: Triamcinolone; Device: Nasopore

Detailed Description

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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 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.
Other: 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.	Drug: 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.; Device: Nasopore; This "packing' is a sponge-like material which dissolves while releasing triamcinolone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Pre-operative score in Patient's nasal endoscopy, as measured by Perioperative Sinus Endoscopy (POSE) Scores	Validated endoscopy grading score.The score is calculated by determining several characteristics of the appearance of the sinus cavities. The score ranges from 0-32 (or 0-40 if frontal and sphenoid sinuses are opened at the time of surgery). A higher score indicates more severe disease.	Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Pre-operative score in Patient's nasal endoscopy, as measured by the Lund-Kennedy Endoscopic Score.	The score is calculated by determining the amount of polyp, edema, and secretion in the nasal cavity on both sides. The score ranges from 0-12, with higher scores indicating more severe disease.	Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.
Change from Pre-operative score in Patient's sinonasal quality of life, as measured by SNOT-22 (Sino-nasal outcome test)	Validated disease-specific quality of life questionnaire (22 questions). The score ranges from 0-110, with higher scores indicating more severe disease.	Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Findings on the pre-operative CT scan, as measured by Lund-MacKay CT Scores	The score is calculated by determining the amount of polyp, edema, and secretion in the nasal cavity on both sides. The score ranges from 0-12, with higher scores indicating more severe disease.	Pre-operatively

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Aaron Pearlman, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Actual): May 26, 2020
• Study Completion (Actual): May 26, 2020

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Triamcinolone; Propel Implant; Nasopore
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: 1802018943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes