Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)

September 10, 2021 updated by: Shin Poong Pharmaceutical Co. Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients at the age of between 19 and 69
  2. 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)
  3. Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
  4. Patients who signed written consent after listening to the objective, method and effects of clinical trial
  5. Patients available during the period of clinical trial

Exclusion Criteria:

  1. Patients with sinusitis on only one nasal cavity
  2. Patients with massive sinonasal polyposis
  3. Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
  4. Patients with ongoing drug administration for asthma
  5. 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
  6. Patients with immunosuppression or autoimmune disease
  7. Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
  8. Patients who had surgery to treat extrasinus complication from rhinosinusitis
  9. 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
  10. Patients with significant liver or kidney diseases
  11. Patients with setting agent administered or with hemostatic or lymph fluid disorders
  12. Patients administered with oral or parenteral drugs for hypoglycemia
  13. Patients with significant systematic disease
  14. Patients with malignant tumor
  15. Patients with infectious disease or suspected of potential problems during the course of healing surgical site (healing disorder)
  16. Those who are pregnant or lactiferous
  17. Women of childbearing age with plan for pregnancy during the clinical trial period
  18. Those who participated in other clinical trials 30 days prior to the participation in this trial
  19. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medicurtain®
Treat GUARDIX-SG 5ml prefilled syringe after surgery
Device: Medicurtain®
Medicurtain® 5ml prefilled syringe
Active Comparator: GUARDIX-SG®
Treat Medicurtain® 5ml prefilled syringe after surgery
Device: GUARDIX-SG®
GUARDIX-SG® 5ml prefilled syringe

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
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
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor
Time Frame: follow up to 4weeks

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.
follow up to 4weeks
Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator
Time Frame: follow up to 4weeks
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
Time Frame: follow up to 4weeks
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
Time Frame: follow up to 4weeks

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
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
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
Time Frame: follow up to 4weeks

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
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence rate of adverse events (AEs)
Time Frame: follow up to 4 weeks
Safety and tolerability by collecting AEs
follow up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shin Poong Pharmaceutical Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMT2012-SP-MC-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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