Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial is to prove that the treatment group of Medicurtain® is non-inferior to the treatment group of Guardix-sol®, test equipment on adhesion after endoscopic sinus surgery, upon the aspects of adhesion prevention efficacy and safety.
This clinical trial was conducted based on multi center, randomized, assessor blind, matched pair design, active-controlled clinical study. After signing consent and fulfilling the standards for selection/exclusion, test subjects went through required treatments following endoscopic surgery; subsequently, according to the order of registration after 2 to 3 days from the surgery, the subjects were applied with a medical device for the clinical test and a medical device for the control test to both of their nasal cavities based on randomization.
For procedures, bleeding was treated and prevented through packing, by soaking Merocel with saline solution following the ESS (Endoscopic sinus surgery) on subjects; and after 2 to 3 days (or upon discharge), it was to treat applied regions of the subjects with assigned medical device after confirming sufficient hemostasis by removing Merocel. Being matched pair active-controlled clinical study, this clinical trial was designed to treat a single subject with both medical devices for clinical test and control test where it was kept unknown which device would be assigned to which nasal cavity based on randomization until the procedure was actually performed. For the time and method of evaluation, observation and evaluation were allowed to be conducted based on the images through endoscopy when subjects visited at 1st, 2nd and 4th weeks following the treatment with medical device. The process of procedure was assured for an identical researcher to perform procedures in order to minimize the effect from the procedure method.
All endoscopic image records of test subjects were delivered by independent assessors, while information on medical device used for treatment was excluded; and independent assessors evaluated each image record according to the evaluation standards prescribed by this clinical trial.
Based on the determination of the researcher during and following the surgery, subjects were administered with 2nd or 3rd generation Cephalosporin Antibiotics. Following the surgery, subjects were instructed to use normal saline solution nasal spray 2 to 3 times a day on both nasal cavities by utilizing bulb-shape tube or syringe. In addition, subjects were also instructed to use intranasal steroid sprays.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medicurtain® | Experimental | Treat GUARDIX-SG 5ml prefilled syringe after surgery |
|
| GUARDIX-SG® | Active Comparator | Treat Medicurtain® 5ml prefilled syringe after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medicurtain® | Device | Medicurtain® 5ml prefilled syringe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between effective ratio (Pt=P00+P01) of medical device for clinical trial and effective ratio (Pc=P00+P10) of medical device for control test evaluated by independent assessor at the 4th week following the application of medical device |
| Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor | Adhesion is to be scored and recorded on the scale of 0 to 3 points, where the adhesion requiring treatments shall be scored at 2 points or higher. Independent assessor must be blind. * Standard for grading score of Synechia
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of adverse events (AEs) | Safety and tolerability by collecting AEs | follow up to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heung-Man Lee, MD | Korea University, Guro Hospital 148 Gurodong-ro, Guro-gu, Seoul | Principal Investigator |
| Kyung-su Kim, MD | Gangnam Severance Hospital Yonsei University, 146-92 Dogok-dong, Gangnam-gu, Seoul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluator-blinded
| GUARDIX-SG® |
| Device |
GUARDIX-SG® 5ml prefilled syringe |
|
| follow up to 4weeks |
| Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator | Adhesion is to be scored and recorded on the scale of 0 to 3 points, where the adhesion requiring treatments shall be scored at 2 points or higher. Investigator is open-state. | follow up to 4weeks |
| Presence of adhesion (decomposition or dissolution) requiring treatments at 4th week | Rate of patient who received 2 or more point in the adhesion assessment with medical devices for clinical trial or control test. | follow up to 4weeks |
| Ratio of study subjects without edema and the extent of edema evaluated at each visit | Edema is to be score and record at the scale of 0 to 3 points, depending on the extensiveness where the case requiring treatments for edema with steroids shall be scored at 2 points or higher. * Standard for grading score of Edema
| follow up to 4weeks |
| Presence of edema requiring treatment evaluated at each visit (Only the cases using oral steroid not for prevention purpose but for treatment purpose) | Rate of patient who received 2 or more point in the edema assessment with medical devices for clinical trial or control test. | follow up to 4weeks |
| Ratio of study subjects without local infection and extent of local infection evaluated at each visit | Infection is to be scored and recorded at the scale of 0 to 2 points where the case requiring treatments for infection shall be scored at 2 points. * Standard for grading score of Infection
| follow up to 4weeks |
| Presence of infection requiring treatment evaluated at each visit (Only the cases using antibiotics not for prevention purpose but for treatment purpose) | Rate of patient who received 2 or more point in the infection assessment with medical devices for clinical trial or control test. | follow up to 4weeks |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |