SinusitisNCT05049434
Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
A study testing Medicurtain® and GUARDIX-SG® in people with Sinusitis and Tissue Adhesion, Surgery-Induced, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Sinusitis, Tissue Adhesion, Surgery-Induced
- What is being tested?
- Medicurtain® and GUARDIX-SG®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Mar 2014to 31 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at the age of between 19 and 69
- Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
- Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
- Patients who signed written consent after listening to the objective, method and effects of clinical trial
- Patients available during the period of clinical trial
Who cannot join
- Patients with sinusitis on only one nasal cavity
- Patients with massive sinonasal polyposis
- Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
- Patients with ongoing drug administration for asthma
- Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
- Patients with immunosuppression or autoimmune disease
Show all 19Show fewer
- Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
- Patients who had surgery to treat extrasinus complication from rhinosinusitis
- Patients with history of endoscopic sinus surgery for other than chronic or relapsed sinusitis, including cerebrospinal fluid (CSF) leak correction, orbital decompression and optic nerve decompression
- Patients with significant liver or kidney diseases
- Patients with setting agent administered or with hemostatic or lymph fluid disorders
- Patients administered with oral or parenteral drugs for hypoglycemia
- Patients with significant systematic disease
- Patients with malignant tumor
- Patients with infectious disease or suspected of potential problems during the course of healing surgical site (healing disorder)
- Those who are pregnant or lactiferous
- Women of childbearing age with plan for pregnancy during the clinical trial period
- Those who participated in other clinical trials 30 days prior to the participation in this trial
- In addition to the above, those who are subject to clinical findings where principal investigator or sub-investigator deem inadequate for this clinical trial based on medical judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi Center, Randomized, Single Blind, Assessor Blind, Matched Pair Design Clinical Study to Evaluate the Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery
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.
Read the detailed description
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.
- Conditions
- Sinusitis, Tissue Adhesion, Surgery-Induced
- Being tested
- Medicurtain®, GUARDIX-SG®
- Keywords
- Medicurtain®, Sodium hyaluronate, Anti-adhesion barrier
- Medical subject headings
- Sinusitis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicurtain®Device
Medicurtain® 5ml prefilled syringe
GUARDIX-SG®Device
GUARDIX-SG® 5ml prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| Medicurtain® | Experimental | Treat GUARDIX-SG 5ml prefilled syringe after surgery Receives: Device: Medicurtain® |
| GUARDIX-SG® | Active comparator | Treat Medicurtain® 5ml prefilled syringe after surgery Receives: Device: GUARDIX-SG® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- P00: Ratio of study subjects without adhesion at the application site with medical devices for clinical trial and control test
- P01: Ratio of study subjects without adhesion only at the application site with medical device for clinical trial
- P10: Ratio of study subjects without adhesion only at the application site with medical device for control trial
Measured: Week 4
Secondary outcomes (7)
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
- Score 0: Synechia not visible
- Score 1: One or a few synechia are visible, but clear hindrance obstructing sinus ventilation is not detected.
- Score 2: Presence of Synechia obstructing sinus ventilation and drainage.
- Score 3: Formation of complete scar between middle turbinate and lateral wall of nose.
Measured: 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.
Measured: 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.
Measured: 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
- Score 0: Mucous membrane edema not visible
- Score 1: Mild mucous membrane edema without extinction of ethmoid sinus
- Score 2: Serious mucous membrane edema with extinction of most ethmoid sinus
- Score 3: Parenchymatous polyposis
Measured: 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.
Measured: 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
- Score 0: Proof of infection not visible
- Score 1: Drainage of mild mucopurulent
- Score 2: Drainage of lumpy mucopurulent accompanying parenchymatous infection
Measured: 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.
Measured: follow up to 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start3 Mar 2014
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heung-Man Lee, MD, Principal investigator, Korea University, Guro Hospital 148 Gurodong-ro, Guro-gu, SeoulKyung-su Kim, MD, Principal investigator, Gangnam Severance Hospital Yonsei University, 146-92 Dogok-dong, Gangnam-gu, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049434
- Sponsor's protocol ID
- UMT2012-SP-MC-04
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Single Blind, Assessor Blind, Matched Pair Design Clinical Study to Evaluate the Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT05049434
- Acronym / sponsor ID
- UMT2012-SP-MC-04
- Conditions
- Sinusitis, Tissue Adhesion, Surgery-Induced
- Keywords
- Medicurtain®, Sodium hyaluronate, Anti-adhesion barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicurtain® | Experimental | Device: Medicurtain®Treat GUARDIX-SG 5ml prefilled syringe after surgery |
| GUARDIX-SG® | Active comparator | Device: GUARDIX-SG®Treat Medicurtain® 5ml prefilled syringe after surgery |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients at the age of between 19 and 69
- Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
- Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
- Patients who signed written consent after listening to the objective, method and effects of clinical trial
- Patients available during the period of clinical trial
Key exclusion criteria (19 listed)
- Patients with sinusitis on only one nasal cavity
- Patients with massive sinonasal polyposis
- Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
- Patients with ongoing drug administration for asthma
- Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicurtain®Medicurtain® 5ml prefilled syringe | Device | Medicurtain® |
| GUARDIX-SG®GUARDIX-SG® 5ml prefilled syringe | Device | GUARDIX-SG® |
Primary outcome
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
Time frame: Week 4
* P00: Ratio of study subjects without adhesion at the application site with medical devices for clinical trial and control test * P01: Ratio of study subjects without adhesion only at the application site with medical device for clinical trial * P10: Ratio of study subjects without adhesion only at the application site with medical device for control trial
7 secondary outcomes
Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor
Time frame: follow up to 4weeks
Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator
Time frame: follow up to 4weeks
Presence of adhesion (decomposition or dissolution) requiring treatments at 4th week
Time frame: follow up to 4weeks
Ratio of study subjects without edema and the extent of edema evaluated at each visit
Time frame: 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)
Time frame: follow up to 4weeks
Ratio of study subjects without local infection and extent of local infection evaluated at each visit
Time frame: 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)
Time frame: follow up to 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heung-Man Lee, MD principal investigator
Korea University, Guro Hospital 148 Gurodong-ro, Guro-gu, Seoul
Kyung-su Kim, MD principal investigator
Gangnam Severance Hospital Yonsei University, 146-92 Dogok-dong, Gangnam-gu, Seoul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicurtain® and GUARDIX-SG® in people with Sinusitis and Tissue Adhesion, Surgery-Induced, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.