Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications

April 30, 2017 updated by: STS Medical

Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent System to Prevent Post-Operative Complications and Revision Surgery

This is a randomized controlled first in man study. Study purpose is to assess safety and efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus surgery in terms of:

  • Sinus tissue adhesions
  • Middle turbinate lateralization into nasal septum i.e. postoperative opening reduction
  • Inflammation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess Composite Removable Sinus Stent safety and efficacy implantation following FESS surgery compared to standard of care.

At first pilot stage, 3-6 patients will be enrolled to this study. At 2nd stage 19-27 additional patients will be enrolled to this study for statistical assurance.

In study group patients will undergo post-FESS bilateral implantation of Composite Removable Sinus Stent into ethmoid sinus under same anesthesia. Stent is inserted upon low pressure balloon catheter. After reaching target position balloon is inflated and stent deployed and secured. Balloon catheter is deflated and removed. Stent implanted for 14-28-day time period (depending on healing process and therapeutic effect). The stent will be removed upon balloon catheter or using medical grasper, following cooling and self-crimping.

In control group patients will undergo post-FESS bilateral tampon placement into middle meatus as standard of care. Tampon will be removed at day 2-3 post surgery.

Patients in pilot study group (group 1) scheduled for 6 follow up visits at 1,2,3,4,6 and 12 weeks after implantation.

Patients in study group (group 2) scheduled for 4 follow up visits at 2, 4, 6 and 12 weeks after implantation.

Patients in control group (group 3) scheduled for 3 follow up visits at 2, 6 and 12 weeks after surgery. All groups scheduled for tampon removal at day 2 - 3 after ESS surgery (if nessecery) .

During follow up visits patients will be examined for:

  • Endoscopic examination of the surgical cavity to assess inflammation, MT position, adhesions and polyposis.

    • Inflammation VAS anchored as o=none and 10cm=severe (significant erythema and edema and/or hypertrophy, and/or polypoid change.
    • Adhesions graded at 5-point scale as none, small but not obstructing, obstructing but easily separated, dense and separation is difficult, severe with complete MT lateralization into lateral nasal wall.
    • MT position graded at 4-point scale as medialized, normal, partially lateralized, and lateralized.
  • SNOT - 22 score - taken prior to FESS and at 12 weeks follow up.
  • Pain questioner - taken at tampon removal day for group 3 and at stent removal day for groups 1 and 2.

Stent will be removed between 14 and 28-day implantation, during self-crimp procedure induced by cold saline wash and safely pulled out. Stent removal performed after adrenaline-lidocaine administration for minimization of bleeding.

Study Discontinuation

  • Patient severe inflammation or pain associated with the stent
  • Patient nasal trauma.
  • Stent migration
  • Nitinol struts exposure as reason for granulation process initiation

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Herzliya, Israel
        • Recruiting
        • Herzliya Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male/Female, 18 year or older
  • Diagnosis of Recurrent Rhinosinusitis defined as symptomatic inflammation of the sinuse of at least 12 consecutive weeks duration
  • CT scan examination with a minimum Lund-MacKay stage of 4 prior to study entry
  • Planned Endoscopic Sinus surgery

Exclusion Criteria:

  • Pregnant or lactating female
  • History of immune deficiency
  • Known allergy to Nickel
  • Known Polyurethane induced dermatitis
  • Cystic Fibrosis
  • Severe Polyposis
  • Sinonasal tumors
  • Ciliary Disfunction
  • Acute Sinus Inflammation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pilot study group 1
Patients in pilot study group 1 will undergo post-FESS bilateral implantation of Composite Removable Sinus Stent into middle meatus. Nasal tampon will be placed to stop bleeding if necessary. Patients in pilot study group scheduled for 6 follow up visits at 1,2,3,4,6 and 12 weeks after implantation and for tampon removal at day 2 - 3 after FESS surgery. Stent will be removed between 14 and 28-day implantation. Before removal adrenaline - lidocaine administration will be used locally to minimize bleeding and cold saline wash applied to induce stent crimping.
Device: Composite Removable Sinus Stent
Post-FESS bilateral implantation of sinus stent into middle meatus. Nasal tampon will be placed to stop bleeding. Stent will be removed after 14 - 28-day implantation, during self-crimp procedure induced by cold saline flush and safely pulled out. During implantation period patients will be examined endoscopically for inflammation, adhesions and middle turbinate position.
Drug: adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
Procedure: cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
Experimental: study group 2
Patients in study group 2 will undergo post-FESS bilateral implantation of Composite Removable Sinus Stent into middle meatus. Nasal tampon will be placed to stop bleeding if necessary. Patients in 2nd study group scheduled for 4 follow up visits at 2, 4, 6 and 12 weeks after implantation. Before removal adrenaline - lidocaine administration will be used locally to minimize bleeding and cold saline wash applied to induce stent crimping.
Device: Composite Removable Sinus Stent
Post-FESS bilateral implantation of sinus stent into middle meatus. Nasal tampon will be placed to stop bleeding. Stent will be removed after 14 - 28-day implantation, during self-crimp procedure induced by cold saline flush and safely pulled out. During implantation period patients will be examined endoscopically for inflammation, adhesions and middle turbinate position.
Drug: adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
Procedure: cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
No Intervention: control group 3
control group patients will undergo post-FESS bilateral Standard of Care (tampon) placement into middle meatus as standard of care. Frontal tampon will be placed to stop bleeding. Patients in control group scheduled for 3 follow up visits at 2, 6 and 12 weeks after surgery and for tampon removal at day 2 - 3 after FESS surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Removable Sinus Stent efficacy compared to standard of care
Time Frame: 12 weeks
The primary objective of this study is to assess Composite Removable Stent efficacy following FESS surgery compared to standard of care, in terms of inflammation, adhesion s, middle turbinate position, and patient symptoms improvement assessed by SNOT-22 questioner.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain associated with Composite Stent removal vs. standard of care removal
Time Frame: 4 weeks
The secondary objective is to assess patients pain associated with Composite Stent removal vs. tampon removal assessed using pain questioner filled in at tampon removal and stent removal days.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient discomfort
Time Frame: 4 weeks
The objective is to assess patient discomfort resulting from stent implantation vs. standard of care implantation, assessed using discomfort questioner filled at tampon and stent removal days.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

STS Medical

Investigators

  • Principal Investigator: Eitan Yaniv, Prof, ENT Surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 30, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 461001P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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