Clinical trial NCT03729310: Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis
Official title: Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Chronic Sinusitis
Rhinosinusitis
Keywords: Propel Implant
Nasopore
Triamcinolone
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Pre-operative score in Patient's nasal endoscopy, as measured by Perioperative Sinus Endoscopy (POSE) Scores
timeFrame: Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.
Secondary outcomes:
measure: Change from Pre-operative score in Patient's nasal endoscopy, as measured by the Lund-Kennedy Endoscopic Score.
timeFrame: Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.
measure: Change from Pre-operative score in Patient's sinonasal quality of life, as measured by SNOT-22 (Sino-nasal outcome test)
timeFrame: Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.
Other outcomes:
measure: Findings on the pre-operative CT scan, as measured by Lund-MacKay CT Scores
timeFrame: Pre-operatively
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Aaron Pearlman, MD
role: PRINCIPAL_INVESTIGATOR
References: