The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)

A Placebo Comparative, Evaluator Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy

This study was designed to assess the safety and efficacy of MEDICURTAIN, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Adhesion formation in both groups was evaluated by the grading scale and photographs taken during the follow up to evaluate the safety and efficacy of the product.

Study Overview

• Status: Completed
• Conditions: Tissue Adhesion, Surgery-Induced; Intrauterine Synechiae
• Intervention / Treatment: Device: Medicurtain®; Device: Placebo

Detailed Description

This study was designed as a multi-center, randomized, evaluator-blinded and placebo-comparative study. A woman aged 20-80 years scheduled for the hysteroscopy was eligible to participate in the study. Subject screening was conducted for the subject who signed an informed consent form. Subjects who met the inclusion/exclusion criteria were randomly assigned into either treatment or no-treatment control group. Follow-up visits were performed at 1 week (Visit 2) and 4 weeks (Visit 3) after the index surgery. Telephone call is made between 1 to 2 weeks prior to the Visit 3 for the information for the follow-up visit and check-up.

At Visit 2 (at Week 1 after the index surgery, a window of ± 2 days was allowed), assessments to identify adverse events and general health conditions, and surgery satisfaction survey were performed. At Visit 3 (at Week 4 ± 4 days), adverse event assessments and general satisfaction survey were performed, and adhesion formations and grades were evaluated. The presence or absence of adhesions, and their grades at Visit 3 (at Week 4 ± 4 days) were assessed in an evaluator-independent manner.

Adhesion formations rate (Primary endpoint) and adhesion grade(secondary endpoint) were assessed at Week 4 after the index surgery (Visit 3), based on the video clips and still images captured via a video monitor during a second-look hysteroscopy, by inserting the hysteroscope (5 -10 mm diameter) into the uterine through the vagina; and graded in an evaluator-blinded manner by an independent evaluator, who did not take part in the index surgery or application of Medicurtain®. Intrauterine adhesion grades were assessed by using the American Fertility Society (AFS) adhesion score established in 1988. It was classified as 4 grading scales (0, 1, 2 and 3 grade). Grade 0 (none) means no adhesion, while Grade 1 to Grade 3 means there are adhesions and severity increased with the grade. Adhesion formation rate and grade in the treated or in the non-treated control groups were compared and evaluated using the Grade 0 to 3 adhesion scoring system.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Woman who is between 20~80 years of age.

2. Woman who is reserved elective hysteroscopy for

   • Uterine polyp
   • Uterine (endometrium) myoma
   • Missed miscarriage (uterine lesion suspected to be associated with pregnancy)
   • Adhesion in uterine
3. Woman who signed an informed consent form prior to the investigation.

Exclusion Criteria:

1. Presence of tumor or inflammatory disease in other organs.
2. Subject who is not eligible for anesthesia or re-operation due to other disease confirmed by investigator.
3. Subject who is not eligible for re-operation or hysteroscopy
4. Any condition which made a subject unsuitable for inclusion in the discretion of the Investigator will be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medicurtain®; Treat Medicurtain 5ml prefilled syringe after hysteroscopy surgery	Device: Medicurtain®; Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after hysteroscopy surgery)
Sham Comparator: Placebo; No device after hysteroscopy surgery	Device: Placebo; No device after hysteroscopy surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome Measure: comparison between treated group and untreated control group for the adhesion rate	Adhesion rate: {(number of subjects occurred adhesion formation for each group)/ (number of subjects for each group)} * 100	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Adhesion Grade between treated group and untreated control group	Adhesive grade evaluation standards are classified into Grade 0(Non), Grade 1(Mild), Grade 2(Moderate), Grade 3(Severe).	4 weeks
The incidence rate of adverse events	Safety and tolerability by collecting adverse events (AEs)	follow up to 4 weeks
The incidence rate of adverse drug reaction	Safety and tolerability by collecting adverse drug reaction (ADRs)	follow up to 4 weeks
The incidence rate of serious adverse events	Safety and tolerability by collecting serious adverse events (SAEs)	follow up to 4 weeks

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Byeongseok Lee, MD, Gangnam Severance Hospital, 712 Eonju-ro, Gangnam, Seoul, South Korea; Principal Investigator: Youngsik Choi, MD, Severance Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul, South Korea; Principal Investigator: Sun Hee Cha, MD, Bundang CHA Medical Center, 351 Yatap-dong, Seongnam-si, Gyeonggi-do, South Korea; Principal Investigator: Joomyung Kim, MD, CHEIL General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, South Korea; Principal Investigator: Ki-Hwan Lee, MD, Chungnam National University Hospital, 33 Munhwa-ro, Jung-gu, Daejeon, South Korea; Principal Investigator: In Taek Hwang, MD, Daejeon Eulji Medical Center, Dunsan-2-dong, Seo-gu, Daejeon, South Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2010
• Primary Completion (Actual): December 3, 2011
• Study Completion (Actual): December 3, 2011

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Medicurtain; Anti-adhesion barrier; Sodium hyaluronate
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Gynatresia
• Other Study ID Numbers: UMT2009-SP-ASMC-0401

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