The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)

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

This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-treatment control group. Adhesion formations at 8 weeks after the index surgery were compared between the two groups by using the well-defined grade scale and image recording.

Study Overview

• Status: Completed
• Conditions: Laparoscopy; Tissue Adhesion, Surgery-Induced; Leiomyoma of the Uterine Body
• Intervention / Treatment: Device: Medicurtain®; Device: Placebo

Detailed Description

This study was designed as multi-center, randomized, evaluator-blinded, comparative study. Subjects were woman between 20~80 years of age reserved with total laparoscopic hysterectomy. Subject screening was conducted for the subject who signed an informed consent form. Subjects who met the inclusion criteria were randomly assigned into either treatment (Medicurtain®) or control group.

Each subject visit clinic for follow-up examination 1week (Visit 2) and 8 weeks (Visit 3) after the index surgery and before the visit subjects were received phone calls. Since the target population was the patient who scheduled elective total laparoscopic hysterectomy, subjects who met the inclusion/exclusion criteria after the examination for the surgery signed on the informed consent at Visit 1 (Baseline: 0 day) and randomly assigned either into the treatment and control group.

At visit 2 (1week±2days), 1week after the index surgery adverse events and general health were examined. At visit 3 (8week±5days), 8 weeks after the index surgery, the investigator inserted endoscope into abdominal cavity and took video clip and still images. If it was necessary, adhesion was removed surgically. An independent evaluator evaluated the records and graded the adhesion rate and its severity according to the grading system. If it was difficult to collect images with endoscope, the investigators recorded his observation for statistical analysis.

The investigator inserted endoscope into abdominal cavity and took video clip and still images at 8weeks after total laparoscopic hysterectomy to evaluate the adhesion formation and its grade. An independent evaluator evaluated the records and graded the adhesion rate and its severity according to the grading system. If it was difficult to collect images with endoscope, the investigators recorded his observation for statistical analysis. The adhesion grading system was proposed by American Fertility Society (AFS) in 1988, grades adhesion with Grade 0, Grade 1, Grade2 and Grade 3. Grade 0 means there is no adhesion formation, Grade 1~Grade 3 means there is adhesion formed, severity increases with the grade. Adhesion rate and grade were evaluated between the treatment and control groups suing Grade 0~3 scales.

General safety of the study device was evaluated based on the adverse event rate, laboratory tests, ECG test. The laboratory tests were conducted before and after the index surgery to evaluate whether the device cause toxicity such as hepatic and renal toxicity for safety evaluation.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul Asan Medical Center Gil, Songpa-gu
    • Seoul, Seoul Asan Medical Center Gil, Songpa-gu, Korea, Republic of
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

• Woman who is reserved with total laparoscopic hysterectomy like:

  • Malignant neoplasm of cervix
  • Malignant neoplasm of uterine body
  • Unspecified malignant neoplasm of cervical region
  • Other and unspecified malignant neoplasm of the female reproductive system
  • Carcinoma in situ of the cervix
  • Other and unspecified carcinoma in situ of the reproductive system Leiomyoma of the uterus
  • Other benign neoplasms of uterus
  • Neoplasm of uncertain behavior of uterus
  • Endometriosis
  • Polyp of corpus uteri
  • Other noninflammatory disorders of uterus, except cervix
  • Cervical dysplasia
  • Congenital malformations of uterus and cervix
  • Injury of uterus
• Woman who signed and informed consent.

Exclusion Criteria:

• Presence of tumor or inflammatory disease in other organs after the laparoscopy or laparoscopic surgery
• Subjects with a history of open surgery or laparoscopic surgery
• Subject who is not eligible for anesthesia or re-operation due to other disease confirmed by investigator
• Subject who is not eligible for re-operation or laparoscopy after laparoscopic surgery
• Subjects using coagulant and subjects with lymphoid disease
• Diabetic subjects administrating oral or parenteral glucose-lowering drugs
• Patients with autoimmune diseases or immune disorders
• Liver disease or kidney disease, surgical subjects including open surgery of gastrointestinal or urinary system
• Subjects judged as inadequate by investigator

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 laparoscopic surgery	Device: Medicurtain®; Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery)
Sham Comparator: Placebo; laparoscopic surgery	Device: Placebo; No device after laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the adhesion rate between the groups	Adhesion rate = (number of subjects who developed adhesion in a group)/ (Total number of subjects for each group)	8 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of adhesion grade based on the severity between the groups	Adhesive grade evaluation standards are classified into Grade 0(None), Grade 1(Mild), Grade 2(Moderate), Grade 3(Severe).	8 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of adverse events	Safety and tolerability by collecting adverse events (AEs)	follow up to 8 weeks
The incidence rate of adverse device event	Safety and tolerability by collecting adverse device event (ADEs)	follow up to 8 weeks
The incidence rate of serious adverse events	Safety and tolerability by collecting serious adverse events (SAEs)	follow up to 8 weeks
QT interval on a 12-lead electrocardiogram (ECG) tracing	Change From baseline in QT Interval	follow up to 8 weeks

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Young-Tak Kim, MD, PhD, Asan Medical Center, Seoul Asan Medical Center Gil, Songpa-gu, Seoul, Korea; Principal Investigator: Tae Jin Kim, MD, PhD, Cheil General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, Korea; Principal Investigator: Yong-Il Kwon, MD, PhD, Kangdong Sacred Heart Hospital, (Gil 1dong445) 150, Seongnae-gil, Gwangsan-gu, Gwangju, Korea

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2011
• Primary Completion (Actual): May 9, 2012
• Study Completion (Actual): May 9, 2012

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 17, 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; Hydroxyethylstarch
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Fibrosis; Neoplasms, Connective Tissue; Cicatrix; Neoplasms, Muscle Tissue; Tissue Adhesions; Leiomyoma; Myofibroma
• Other Study ID Numbers: UMT2009-SP-ASMC-0301

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