LaparoscopyNCT04672421
The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
A study testing Medicurtain® in people with Laparoscopy and Tissue Adhesion, Surgery-Induced, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Laparoscopy, Tissue Adhesion, Surgery-Induced, Leiomyoma of the Uterine Body
- What is being tested?
- Medicurtain®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2011to 9 May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul, Seoul Asan Medical Center Gil, Songpa-gu
About this study
Official title: 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.
Read the 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.
- Being tested
- Medicurtain®, Placebo
- Keywords
- Medicurtain®, Sodium hyaluronate, Hydroxyethylstarch, Anti-adhesion barrier
- Medical subject headings
- Tissue Adhesions, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicurtain®Device
Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery)
PlaceboDevice
No device after laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Medicurtain® | Experimental | Treat Medicurtain® 5ml prefilled syringe after laparoscopic surgery Receives: Device: Medicurtain® |
| Placebo | Sham comparator | laparoscopic surgery Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks after surgery
Secondary outcomes (1)
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).
Measured: 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Apr 2011
- Primary completion9 May 2012
- Study completion9 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Tak Kim, MD, PhD, Principal investigator, Asan Medical Center, Seoul Asan Medical Center Gil, Songpa-gu, Seoul, KoreaTae Jin Kim, MD, PhD, Principal investigator, Cheil General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, KoreaYong-Il Kwon, MD, PhD, Principal investigator, Kangdong Sacred Heart Hospital, (Gil 1dong445) 150, Seongnae-gil, Gwangsan-gu, Gwangju, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672421
- Sponsor's protocol ID
- UMT2009-SP-ASMC-0301
- Status last verified
- Sep 2021
- First submitted
- 29 Nov 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim 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.
PubMed 42411725
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Evaluator Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04672421
- Acronym / sponsor ID
- UMT2009-SP-ASMC-0301
- Keywords
- Medicurtain®, Sodium hyaluronate, Hydroxyethylstarch, Anti-adhesion barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2011 (actual)
- Primary completion
- 9 May 2012 (actual)
- Study completion
- 9 May 2012 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicurtain® | Experimental | Device: Medicurtain®Treat Medicurtain® 5ml prefilled syringe after laparoscopic surgery |
| Placebo | Sham comparator | Device: Placebolaparoscopic surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Woman who is between 20~80 years of age.
- Woman who is reserved with total laparoscopic hysterectomy like:
- Woman who signed and informed consent.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicurtain®Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery) | Device | Medicurtain® |
| PlaceboNo device after laparoscopic surgery | Device | Placebo |
Primary outcome
Comparison of the adhesion rate between the groups
Time frame: 8 weeks after surgery
Adhesion rate = (number of subjects who developed adhesion in a group)/ (Total number of subjects for each group)
1 secondary outcome
Comparison of adhesion grade based on the severity between the groups
Time frame: 8 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 42411725Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Tak Kim, MD, PhD principal investigator
Asan Medical Center, Seoul Asan Medical Center Gil, Songpa-gu, Seoul, Korea
Tae Jin Kim, MD, PhD principal investigator
Cheil General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, Korea
Yong-Il Kwon, MD, PhD principal investigator
Kangdong Sacred Heart Hospital, (Gil 1dong445) 150, Seongnae-gil, Gwangsan-gu, Gwangju, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicurtain® in people with Laparoscopy and Tissue Adhesion, Surgery-Induced, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the adhesion rate between the groups (time frame: 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.