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The Feasibility of Using MRI During ESS (ESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903432
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Assuta Medical Center
Information provided by (Responsible Party):
Roee Landsberg, Assuta Medical Center

Brief Summary:

Before performing endoscopic sinus surgery (ESS-Endoscopic Sinus Surgery), every candidate for surgery is referred to perform a sinus CT scan of the sinuses. Because of the complicated anatomy of the sinuses and their proximity to vital organs such as the brain, eye, and carotid artery, the surgeon use the CT imaging during surgery to adjust the anatomy and to avoid complications such as blindness, brain damage and massive bleeding (0.3%). Sometimes the CT is integrated into a navigation system, although there is no evidence that the use of navigation systems reduces the rate of complications.

The aim of our study is to examine whether ESS can be performed in chronic sinusitis patients using MRI, with CT being used as a backup only.


Condition or disease Intervention/treatment Phase
Chronic Sinusitis Other: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Feasibility of Using MRI During Endoscopic Sinus Surgery
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
45 participants, in one center - Assuta
Patients with chronic sinusitis who are scheduled to undergo ESS at Assuta will be recruited and patients will sign an informed consent form for performing MRI (new protocol-without gadolinium injection) in addition to the routine CT.
Other: MRI
candidates for ESS will be referred to conventional CT scans of the sinuses. If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI.
Other Name: CT




Primary Outcome Measures :
  1. Ease and saftey of use of MRI compared to CT during ESS [ Time Frame: imediatly after surgery is done (+- 12 hours) ]

    A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery.

    1. What was your general feeling about this surgery using MRI as compared to a similar surgery in which you used CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE
    2. Safety level using MRI compared to CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE
    3. please rate the level of Ease of work in the different sinus groups (on a scale of 1-2-3 where 1- easy 2- somewhat easy 3- not easy)

  2. the impact of using MRI compared to CT during ESS Ease and saftey of use of MRI compared to CT during ESS [ Time Frame: imediatly after surgery is done (+- 12 hours) ]

    A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery.

    1. How many times was there a sporadic Use of CT during surgery (1-3 times)? (yes / no)
    2. Was there a need for Continuous work with CT? (yes / no)
    3. were there any complications when working with MRI ( no / yes, if yes please elaborate)
    4. Do you think that an exposure to CT imaging would have changed the operation? If yes please elaborate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with chronic sinusitis.
  2. Patients designated for ESS surgery.

Exclusion Criteria:

  1. Patients who have already undergone ESS and/ or nasal septum/ turbinates surgery.
  2. Patients with sinus cancer.
  3. Patients after sinus injury.
  4. Patients under 18 years of age.
  5. Extreme Situations: The radiologist who analyzes the CT and MRI will warn of situations in which he or she will detect an increased risk of injury to vital organs.

These situations will include:

A. Dehiscence, as seen in CT, in the bony walls of:

  1. The carotid artery.
  2. Skull base.
  3. Medial wall of the orbit.

B. Situations in which an anatomical anomaly or distortion of the nasal or sinus cavity is observed in the CT imaging.

C. Situations in which the radiologist identifies poor technical quality of the MRI, and, in particular, a poor demonstration of the bony components.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903432


Contacts
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Contact: Roee Landsberg, M.D +972524266359 roeela@assuta.co.il

Locations
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Israel
Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv
Tel Aviv, Israel, 972
Contact: Assuta Hospital    +972-3-7645464      
Sponsors and Collaborators
Roee Landsberg
Assuta Medical Center
Investigators
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Principal Investigator: Roee Landsberg, M.D Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv
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Responsible Party: Roee Landsberg, Principal Investigator, Assuta Medical Center
ClinicalTrials.gov Identifier: NCT03903432    
Other Study ID Numbers: 0059-18-ASMC
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roee Landsberg, Assuta Medical Center:
MRI
CT
Chronic Sinusitis
ESS
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases