Safety and Performance of the Steroid-Releasing S8 Sinus Implant

NCT01894503 | Completed Phase 2 Results DMC

• 1 other identifier: P500-0513
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

• Number of Sinuses With Successful Implant Delivery

  Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure

  End of baseline procedure

Secondary Outcomes (1)

• Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ

  Days 3, 7, 14, 21 and 30

Study Arms (1)

S8 Sinus Implant

EXPERIMENTAL

Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)

Interventions

S8 Sinus Implant (mometasone furoate, 1350 mcg) DRUG

Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days

Also known as: SINUVA (mometasone furoate) sinus implant

S8 Sinus Implant

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Diagnosis of chronic sinusitis
• Prior bilateral total ethmoidectomy
• Recurrent sinus obstruction due to polyps grade 2 or higher

You may not qualify if:

• Required use of mometasone furoate within 2 weeks prior to implant procedure
• Significant scarring or adhesions of the sinus

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (1)

Sacramento ENT

Sacramento, California, 95815, United States

Location

MeSH Terms

Interventions

Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: James Stambaugh, Vice President of Clinical & Medical Affairs
• Organization: Intersect ENT, Inc.

jstambaugh@intersectent.com

650-641-2103

Study Officials

• Randall Ow, MD

  Sacramento ENT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 18, 2018
• Results First Posted: June 25, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)