None listed
Conditions
Brief summary
The current standard of practice for the treatment of CRS includes antibiotics either given by mouth or through an injection in your arm, nasal sprays and rinses, oral and nasal corticosteroids and/or anti-allergy medicines. Despite these treatments some patients are still unable to get relief from their sinus symptoms. When the above treatments fail and the disease continues then some patients will move forward to surgery. This type of surgery is called “Functional Endoscopic Sinus Surgery (FESS)”. The surgery is quite difficult and requires great surgical skill. One of the problems associated with FESS surgery is making sure that the area being treated is clear of blood so the surgeon can see the area he is treating. There are a number of complications associated with bleeding with this type of surgery which your doctor will explain to you. A potential solution to try and improve the visibility when performing FESS surgery is to use laser throughout the procedure. Laser is used in many types of surgery, including surgery for ears, nose and the throat (otolaryngology). The laser being tested during this study is a new laser. It has been designed so that it delivers the laser through a much smaller fibre (a tube that delivers the light to the tissue) and also uses very low power to avoid unwanted damage to nearby healthy tissue, which will hopefully help achieve better results from surgery and also fewer complications with this type of surgery. This study is being done to look at the safety and the performance of this new laser when it is used during FESS procedures. It is important to remember that you would have undergone the surgery regardless of this new laser – the new laser is an additional treatment being used during the procedure.
Interventions
Participants in this study have chronic rhinosinusitis (CRS) that is not controlled by medical treatment. It is important to remember that participants would have been offered Functional Endoscopic Sinus Surgery (FESS) surgery for the treatment of CRS, regardless of whether this new laser was available or not.
The intervention treatment is the PLS Opel Surgical System is a compact solid state surgical laser system.
In this within-participant controlled study, each participant will receive i
Participants in this study have chronic rhinosinusitis (CRS) that is not controlled by medical treatment. It is important to remember that participants would have been offered Functional Endoscopic Sinus Surgery (FESS) surgery for the treatment of CRS, regardless of whether this new laser was available or not. The intervention treatment is the PLS Opel Surgical System is a compact solid state surgical laser system. In this within-participant controlled study, each participant will receive investigational treatment and conventional surgical instruments to one sinus and conventional surgical instruments alone to the other sinus. The surgeon will decide which conventional instruments to use and how much laser is required during the surgery. Participants will be treated in day surgery. The total time of surgery will depend on the type of FESS needed, but is anticipated to be under 1 hour. The time of surgery and time using the investigational treatment will be measured in minutes.
Sponsors
Five Corners
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Male or female participant Aged between 18 to 70 years inclusive Are free of any disease or physical condition which might, in the investigator’s opinion, expose the participant to an unacceptable risk by study participation; Abnormal CT scan indicative of CRS; Clinical signs and symptoms present at screening of CRS including headache, facial pain, facial pressure, congestion, and/or post-nasal drip; Documented history of CRS (polypoid or non-polypoid), suggestive of inflammation and infection for at least 90 consecutive days prior to the Screening Visit, who have failed conventional medical therapy for the condition; Bilaterally similar disease in the right and left anterior ethmoid sinuses and/or turbinates as determined by the study investigator; Clinically indicated for anterior ethmoidectomy and/or turbinate reduction during FESS as determined by the study investigator; Agreement to follow the study requirements and restrictions including attending all visits and permitting all required assessments.
Exclusion criteria
Women of childbearing potential who are pregnant and/or lactating, Participants unlikely to comply with protocol procedures or adhere to the study visit schedule; Previous turbinate and/or anterior ethmoidectomy surgical procedures; (Please Note If participant is scheduled for turbinate surgery, they must not have had previous turbinate surgical procedures, however they can have had previous anterior ethmoidectomy surgical procedures. Note: if participant is scheduled for anterior ethmoidectomy surgical procedures, they must not have had previous anterior ethmoidectomy surgical procedures however they can have had prior turbinate surgical procedures). Any medical condition that in the opinion of the investigator might jeopardize the participant’s safety and/or cause ineligibility to undergo FESS, including, but not limited to: Major surgery within 30 days prior to the Screening Visit, or planned surgery during the study period; Diagnosed bleeding disorders, such as hemophilia, Ongoing regimens of anti-coagulants (e.g., warfarin), medications (e.g. NSAIDs), vitamins (e.g. high doses vitamin E or C), herbal remedies (e.g. gingko biloba, ginseng, St. John’s Wort) or other substances (e.g. excessive amounts of garlic) known to increase coagulation time within 14 days prior to the Randomization/Surgery Visit at Day 0. Donation of blood/plasma and/or any significant blood loss for any reason greater than 450 ml within 30 days prior to Screening Visit, or during the study period; Concurrent enrollment in another investigational drug or device study; or use of any experimental or investigational drug or device within 30 days, or for drugs within 6 times the elimination half-life, if that is longer, prior to the Screening Visit; Any condition rendering a participant unable to understand the nature, scope, and possible consequences of the study or study procedures.
Outcome results
None listed