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

NCT05049434 | Completed DMC

• 1 other identifier: UMT2012-SP-MC-04
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinusitis; Tissue Adhesion, Surgery-Induced

Keywords

Medicurtain®; Sodium hyaluronate; Anti-adhesion barrier

Outcome Measures

Primary Outcomes (1)

• 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

  Week 4

Secondary Outcomes (7)

• Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor

  follow up to 4weeks

• Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator

  follow up to 4weeks

• Presence of adhesion (decomposition or dissolution) requiring treatments at 4th week

  follow up to 4weeks

• Ratio of study subjects without edema and the extent of edema evaluated at each visit

  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)

  follow up to 4weeks

Other Outcomes (1)

• The incidence rate of adverse events (AEs)

  follow up to 4 weeks

Study Arms (2)

Medicurtain®

EXPERIMENTAL

Treat GUARDIX-SG 5ml prefilled syringe after surgery

Device: Medicurtain®

GUARDIX-SG®

ACTIVE COMPARATOR

Treat Medicurtain® 5ml prefilled syringe after surgery

Device: GUARDIX-SG®

Interventions

Medicurtain® DEVICE

Medicurtain® 5ml prefilled syringe

Medicurtain®

GUARDIX-SG® DEVICE

GUARDIX-SG® 5ml prefilled syringe

GUARDIX-SG®

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Sinusitis; Tissue Adhesions

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Evaluator-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: March 3, 2014
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)