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

Sponsor

Shin Poong Pharmaceutical Co. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04672421

Collaborator

(none)

107

Enrollment

Location

Arms

12.7

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopy Tissue Adhesion, Surgery-Induced Leiomyoma of the Uterine Body	Device: Medicurtain® Device: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Evaluator-blinded

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 18, 2011

Actual Primary Completion Date :

May 9, 2012

Actual Study Completion Date :

May 9, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of the adhesion rate between the groups [8 weeks after surgery]
Adhesion rate = (number of subjects who developed adhesion in a group)/ (Total number of subjects for each group)

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Seoul Asan Medical Center Gil, Songpa-gu	Korea, Republic of

Sponsors and Collaborators

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