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Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by STS Medical
Sponsor:
Information provided by (Responsible Party):
STS Medical
ClinicalTrials.gov Identifier:
NCT02812199
First received: June 9, 2016
Last updated: April 30, 2017
Last verified: April 2017
  Purpose

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

Condition Intervention
Chronic Sinusitis Device: Composite Removable Sinus Stent Drug: adrenaline-lidocaine Procedure: cold saline wash

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent System to Prevent Post-Operative Complications and Revision Surgery

Resource links provided by NLM:


Further study details as provided by STS Medical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Pain associated with Composite Stent removal vs. standard of care removal [ Time Frame: 4 weeks ]
    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.


Other Outcome Measures:
  • Patient discomfort [ Time Frame: 4 weeks ]
    The objective is to assess patient discomfort resulting from stent implantation vs. standard of care implantation, assessed using discomfort questioner filled at tampon and stent removal days.


Estimated Enrollment: 30
Study Start Date: August 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Drug: adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
Procedure: cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
Experimental: 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.
Device: 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.
Drug: adrenaline-lidocaine
adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
Procedure: cold saline wash
nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
No Intervention: 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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02812199

Contacts
Contact: Miriam Sror +972-54-7387188 j.flomen@ststent.com
Contact: Joseph Flomenblit Flomenblit, PhD +972-54-7387188 j.flomen@ststent.com

Locations
Israel
Herzliya Medical Center Recruiting
Herzliya, Israel
Contact: Miriam Sror    972 549457540    Miriams@hmc.co.il   
Sponsors and Collaborators
STS Medical
Investigators
Principal Investigator: Eitan Yaniv, Prof ENT Surgeon
  More Information

Responsible Party: STS Medical
ClinicalTrials.gov Identifier: NCT02812199     History of Changes
Other Study ID Numbers: 461001P
Study First Received: June 9, 2016
Last Updated: April 30, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sinusitis
Postoperative Complications
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathologic Processes
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents

ClinicalTrials.gov processed this record on June 23, 2017