An interventional study of Medicurtain® and Placebo in Laparoscopy, Tissue Adhesion, Surgery-Induced and Leiomyoma of the Uterine Body, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Not applicable, Interventional, and Prevention
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.
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 107 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Woman who is reserved with total laparoscopic hysterectomy like:
Exclusion Criteria:
Treat Medicurtain® 5ml prefilled syringe after laparoscopic surgery
Device: Medicurtain®
laparoscopic surgery
Device: Placebo
Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery)
No device after laparoscopic surgery
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)
Time frame: 8 weeks after surgery
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).
Time frame: 8 weeks after surgery
The incidence rate of adverse events
Safety and tolerability by collecting adverse events (AEs)
Time frame: follow up to 8 weeks
The incidence rate of adverse device event
Safety and tolerability by collecting adverse device event (ADEs)
Time frame: follow up to 8 weeks
The incidence rate of serious adverse events
Safety and tolerability by collecting serious adverse events (SAEs)
Time frame: follow up to 8 weeks
QT interval on a 12-lead electrocardiogram (ECG) tracing
Change From baseline in QT Interval
Time frame: follow up to 8 weeks
Plan to share: No
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Shin Poong Pharmaceutical Co. Ltd.