Chronic SinusitisNCT02812199
Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
A study testing Composite Removable Sinus Stent, adrenaline-lidocaine and cold saline wash in people with Chronic Sinusitis, run by STS Medical at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Composite Removable Sinus Stent, adrenaline-lidocaine and cold saline wash
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating female
- History of immune deficiency
- Known allergy to Nickel
- Known Polyurethane induced dermatitis
- Cystic Fibrosis
- Severe Polyposis
Show all 9Show fewer
- Sinonasal tumors
- Ciliary Disfunction
- Acute Sinus Inflammation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Herzliya Medical Center
Herzliya
Miriam Sror, 972 549457540, Miriams@hmc.co.il
About this study
Official title: 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
Read the 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
- Conditions
- Chronic Sinusitis
- Being tested
- Composite Removable Sinus Stent, adrenaline-lidocaine, cold saline wash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite Removable Sinus StentDevice
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-lidocaineDrug
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
cold saline washProcedure or surgery
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
| Study group | Role | What they receive |
|---|---|---|
| pilot study group 1 | Experimental | 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. Receives: Device: Composite Removable Sinus Stent; Drug: adrenaline-lidocaine; Procedure: cold saline wash |
| study group 2 | Experimental | 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. Receives: Device: Composite Removable Sinus Stent; Drug: adrenaline-lidocaine; Procedure: cold saline wash |
| control group 3 | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Pain associated with Composite Stent removal vs. standard of care removal
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STS Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eitan Yaniv, Prof, Principal investigator, ENT Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812199
- Sponsor's protocol ID
- 461001P
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2016
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent System to Prevent Post-Operative Complications and Revision Surgery
- ClinicalTrials.gov ID
- NCT02812199
- Acronym / sponsor ID
- 461001P
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- STS MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pilot study group 1 | Experimental | Device: Composite Removable Sinus Stent, Drug: adrenaline-lidocaine, Procedure: cold saline washPatients 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 | Experimental | Device: Composite Removable Sinus Stent, Drug: adrenaline-lidocaine, Procedure: cold saline washPatients 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnant or lactating female
- History of immune deficiency
- Known allergy to Nickel
- Known Polyurethane induced dermatitis
- Cystic Fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composite Removable Sinus StentPost-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. | Device | pilot study group 1, study group 2 |
| adrenaline-lidocaineadrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2) | Drug | pilot study group 1, study group 2 |
| cold saline washnasal wash with cold saline prior to stent removal, to induce stent self-crimping. | Procedure or surgery | pilot study group 1, study group 2 |
Primary outcome
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.
1 secondary outcome
Pain associated with Composite Stent removal vs. standard of care removal
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eitan Yaniv, Prof principal investigator
ENT Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite Removable Sinus Stent, adrenaline-lidocaine and cold saline wash in people with Chronic Sinusitis, run by STS Medical at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Sror (+972-54-7387188, j.flomen@ststent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Removable Sinus Stent efficacy compared to standard of care (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.