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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03729310
• Other study ID #: 1802018943
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: March 2020
• Est. completion date: May 26, 2020

Study information

• Verified date: May 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 26, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Sinusitis
• Rhinosinusitis
• Sinusitis

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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.
Secondary	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.