Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
NCT ID: NCT02812199
Last Updated: 2017-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-08-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Sinus tissue adhesions
* Middle turbinate lateralization into nasal septum i.e. postoperative opening reduction
* Inflammation
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
NCT00912405
Debridement and Functional Endoscopic Sinus Surgery
NCT04093193
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
NCT01525849
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
NCT00840970
Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation
NCT03304951
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
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.
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.
adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of immune deficiency
* Known allergy to Nickel
* Known Polyurethane induced dermatitis
* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* Ciliary Disfunction
* Acute Sinus Inflammation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
STS Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eitan Yaniv, Prof
Role: PRINCIPAL_INVESTIGATOR
ENT Surgeon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Herzliya Medical Center
Herzliya, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
461001P
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.