Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out

NCT03534362 | Terminated Results DMC FDA Device

• 1 other identifier: 28525
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuses become one large sinus. This is done with sharp instruments and rigid endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids or both may be used to try to help make sure that the opening does not close back up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use together is part of the study and not specifically FDA-approved. A previous study shows that Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like to know whether this is true in larger frontal sinus surgery where one common cavity is made and whether both steroid-containing stents are the same.

Conditions

Stent; Sinusitis, Frontal

Keywords

Propel Stent; Nasopore

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Sino-Nasla Outcome Test (SNOT-22) Scores

  To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.

  After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.

Secondary Outcomes (2)

• Surgical Postoperative Complications, Devices

  After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.

• Surgical Postoperative Complications, Frontal Sinus Pathology

  After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.

Study Arms (2)

Nasopore Group

ACTIVE COMPARATOR

Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.

Device: Nasopore

Propel Stent Group

ACTIVE COMPARATOR

Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.

Device: Propel

Interventions

Nasopore DEVICE

Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract

Nasopore Group

Propel DEVICE

Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.

Propel Stent Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients able to speak and understand English
• Patients for whom frontal drill out procedure is medically indicated

You may not qualify if:

• Patients who are cognitively impaired and unable to consent
• Patients who are not candidates for Frontal Drill out
• Patients with contraindications to PROPEL Mini sinus implant or Kenalog soaked nasopore: known hypersensitivity to mometasone furoate, Kenalog, lactide, glycolide or caprolactone copolymers
• Non-English speaking patients

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis Universtiy

St Louis, Missouri, 63110, United States

Location

Related Publications (9)

• Gross CW, Harrison SE. The modified Lothrop procedure: indications, results, and complications. Otolaryngol Clin North Am. 2001 Feb;34(1):133-7. doi: 10.1016/s0030-6665(05)70301-7.

  PMID: 11344068 BACKGROUND

• Anderson P, Sindwani R. Safety and efficacy of the endoscopic modified Lothrop procedure: a systematic review and meta-analysis. Laryngoscope. 2009 Sep;119(9):1828-33. doi: 10.1002/lary.20565.

  PMID: 19554631 BACKGROUND

• Eloy P, Vlaminck S, Jorissen M, Hellings P, Timmermans M, Daele J, Ransky P, Hassid S, Van Zele T, Bachert C, Poirrier AL, Bertrand B. Type III frontal sinusotomy: surgical technique, indications, outcomes, a multi-university retrospective study of 120 cases. B-ENT. 2011;7 Suppl 17:3-13.

  PMID: 22338369 BACKGROUND

• Weber RK, Hosemann W. Comprehensive review on endonasal endoscopic sinus surgery. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2015 Dec 22;14:Doc08. doi: 10.3205/cto000123. eCollection 2015.

  PMID: 26770282 BACKGROUND

• Hunter B, Silva S, Youngs R, Saeed A, Varadarajan V. Long-term stenting for chronic frontal sinus disease: case series and literature review. J Laryngol Otol. 2010 Nov;124(11):1216-22. doi: 10.1017/S0022215110001052. Epub 2010 May 20.

  PMID: 20482950 BACKGROUND

• Hoyt WH 3rd. Endoscopic stenting of nasofrontal communication in frontal sinus disease. Ear Nose Throat J. 1993 Sep;72(9):596-7.

  PMID: 8223289 BACKGROUND

• Ting JY, Wu A, Metson R. Frontal sinus drillout (modified Lothrop procedure): long-term results in 204 patients. Laryngoscope. 2014 May;124(5):1066-70. doi: 10.1002/lary.24422. Epub 2013 Nov 13.

  PMID: 24114727 BACKGROUND

• Huang Z, Hwang P, Sun Y, Zhou B. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Syst Rev. 2015 Jun 10;2015(6):CD010436. doi: 10.1002/14651858.CD010436.pub2.

  PMID: 26068957 BACKGROUND

• Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1.

  PMID: 27363723 BACKGROUND

MeSH Terms

Conditions

Frontal Sinusitis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.

Results Point of Contact

• Title: Joe D Brunworth, MD
• Organization: Saint Louis University

joe.brunworth@health.slu.edu

314-577-8884

Study Officials

• Joe D Brunworth, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients eligible for the study and consenting to participate will be randomly assigned to one of two treatment groups: 1) Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract and 2) Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-blind (Subject) randomized, active control study. Subjects will be randomized 1:1 using the rand function in Microsoft Excel program.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 23, 2018
• Study Start: April 13, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)