Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopy | — | UNRESOLVED | — |
| Leiomyoma of the Uterine Body | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Tissue Adhesion, Surgery-Induced | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medicurtain® | Device | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Medicurtain®
- description
- Treat Medicurtain® 5ml prefilled syringe after laparoscopic surgery
- interventionNames
- Device: Medicurtain®
- type
- SHAM_COMPARATOR
- label
- Placebo
- description
- laparoscopic surgery
- interventionNames
- Device: Placebo
Primary outcomes (1)
- measure
- Comparison of the adhesion rate between the groups
- timeFrame
- 8 weeks after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim Y, Choi J, Kim T, Kwon Y, Jeong Y. Evaluator-blinded, randomized, multi-center study to evaluate the efficacy and safety of Medicurtain(R) in patients undergoing laparoscopic hysterectomy. J Gynecol Oncol. 2026 Jun 22. doi: 10.3802/jgo.2026.37.e128. Online ahead of print. PMID 42411725