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

NCT03729310 | Withdrawn Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 1802018943
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis; Rhinosinusitis

Keywords

Propel Implant; Nasopore; Triamcinolone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Pre-operative score in Patient's nasal endoscopy, as measured by the Lund-Kennedy Endoscopic Score.

  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)

  Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.

Other Outcomes (1)

• Findings on the pre-operative CT scan, as measured by Lund-MacKay CT Scores

  Pre-operatively

Study Arms (2)

Propel Implant

OTHER

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'

Nasopore soaked with triamcinolone

OTHER

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; Device: Nasopore

Interventions

Propel 'implant' 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.

Propel Implant

Triamcinolone 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 soaked with triamcinolone

Nasopore DEVICE

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

Nasopore soaked with triamcinolone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Aaron Pearlman, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 2, 2018
• Study Start: March 1, 2020
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)