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

NCT ID: NCT04638855

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-08
• Study Completion Date: 2011-12-03

Brief Summary

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.

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.

Conditions

Intrauterine Synechiae; Tissue Adhesion, Surgery-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Medicurtain®

Treat Medicurtain 5ml prefilled syringe after hysteroscopy surgery

Group Type: EXPERIMENTAL

Medicurtain®

Intervention Type: DEVICE

Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after hysteroscopy surgery)

Placebo

No device after hysteroscopy surgery

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DEVICE

No device after hysteroscopy surgery

Interventions

Medicurtain®

Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after hysteroscopy surgery)

Intervention Type: DEVICE

Placebo

No device after hysteroscopy surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byeongseok Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital, 712 Eonju-ro, Gangnam, Seoul, South Korea

Youngsik Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul, South Korea

Sun Hee Cha, MD

Role: PRINCIPAL_INVESTIGATOR

Bundang CHA Medical Center, 351 Yatap-dong, Seongnam-si, Gyeonggi-do, South Korea

Joomyung Kim, MD

Role: PRINCIPAL_INVESTIGATOR

CHEIL General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, South Korea

Ki-Hwan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital, 33 Munhwa-ro, Jung-gu, Daejeon, South Korea

In Taek Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Daejeon Eulji Medical Center, Dunsan-2-dong, Seo-gu, Daejeon, South Korea

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

UMT2009-SP-ASMC-0401

Identifier Type: -

Identifier Source: org_study_id