Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
1 other identifier
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 2, 2017
April 1, 2017
1.3 years
June 9, 2016
April 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Removable Sinus Stent efficacy compared to standard of care
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 Outcomes (1)
Pain associated with Composite Stent removal vs. standard of care removal
4 weeks
Other Outcomes (1)
Patient discomfort
4 weeks
Study Arms (3)
pilot study group 1
EXPERIMENTALPatients 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.
study group 2
EXPERIMENTALPatients 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.
control group 3
NO INTERVENTIONcontrol 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.
Interventions
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.
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- STS Medicallead
Study Sites (1)
Herzliya Medical Center
Herzliya, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Eitan Yaniv, Prof
ENT Surgeon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 24, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 2, 2017
Record last verified: 2017-04