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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:
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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.
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.
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30 participants in 3 patient groups
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Central trial contact
Joseph Flomenblit Flomenblit, PhD; Miriam Sror
Data sourced from clinicaltrials.gov
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