Clinical trial NCT02812199: Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
Official title: Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent System to Prevent Post-Operative Complications and Revision Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: STS Medical
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Composite Removable Sinus Stent efficacy compared to standard of care
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain associated with Composite Stent removal vs. standard of care removal
timeFrame: 4 weeks
Other outcomes:
measure: Patient discomfort
timeFrame: 4 weeks
Locations:
city: Herzliya
country: Israel
facility: Herzliya Medical Center
Study officials:
affiliation: ENT Surgeon
name: Eitan Yaniv, Prof
role: PRINCIPAL_INVESTIGATOR
References: