Intrauterine SynechiaeNCT04638855
The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)
A study testing Medicurtain® in people with Intrauterine Synechiae 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, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Intrauterine Synechiae, Tissue Adhesion, Surgery-Induced
- 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
- 223 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Sep 2010to 3 Dec 2011
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman who is between 20~80 years of age.
- Woman who is reserved elective hysteroscopy for
- Uterine polyp
- Uterine (endometrium) myoma
- Missed miscarriage (uterine lesion suspected to be associated with pregnancy)
- Adhesion in uterine
- Woman who signed an informed consent form prior to the investigation.
Who cannot join
- Presence of tumor or inflammatory disease in other organs.
- 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 hysteroscopy
- Any condition which made a subject unsuitable for inclusion in the discretion of the Investigator will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo Comparative, Evaluator Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy
This study was designed to assess the safety and efficacy of MEDICURTAIN, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Adhesion formation in both groups was evaluated by the grading scale and photographs taken during the follow up to evaluate the safety and efficacy of the product.
Read the detailed description
This study was designed as a multi-center, randomized, evaluator-blinded and placebo-comparative study. A woman aged 20-80 years scheduled for the hysteroscopy was eligible to participate in the study. Subject screening was conducted for the subject who signed an informed consent form. Subjects who met the inclusion/exclusion criteria were randomly assigned into either treatment or no-treatment control group. Follow-up visits were performed at 1 week (Visit 2) and 4 weeks (Visit 3) after the index surgery. Telephone call is made between 1 to 2 weeks prior to the Visit 3 for the information for the follow-up visit and check-up.
At Visit 2 (at Week 1 after the index surgery, a window of ± 2 days was allowed), assessments to identify adverse events and general health conditions, and surgery satisfaction survey were performed. At Visit 3 (at Week 4 ± 4 days), adverse event assessments and general satisfaction survey were performed, and adhesion formations and grades were evaluated. The presence or absence of adhesions, and their grades at Visit 3 (at Week 4 ± 4 days) were assessed in an evaluator-independent manner.
Adhesion formations rate (Primary endpoint) and adhesion grade(secondary endpoint) were assessed at Week 4 after the index surgery (Visit 3), based on the video clips and still images captured via a video monitor during a second-look hysteroscopy, by inserting the hysteroscope (5 -10 mm diameter) into the uterine through the vagina; and graded in an evaluator-blinded manner by an independent evaluator, who did not take part in the index surgery or application of Medicurtain®. Intrauterine adhesion grades were assessed by using the American Fertility Society (AFS) adhesion score established in 1988. It was classified as 4 grading scales (0, 1, 2 and 3 grade). Grade 0 (none) means no adhesion, while Grade 1 to Grade 3 means there are adhesions and severity increased with the grade. Adhesion formation rate and grade in the treated or in the non-treated control groups were compared and evaluated using the Grade 0 to 3 adhesion scoring system.
- Being tested
- Medicurtain®, Placebo
- Keywords
- Medicurtain, Sodium hyaluronate, Anti-adhesion barrier
- Medical subject headings
- Gynatresia, Tissue Adhesions
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 hysteroscopy surgery)
PlaceboDevice
No device after hysteroscopy surgery
| Study group | Role | What they receive |
|---|---|---|
| Medicurtain® | Experimental | Treat Medicurtain 5ml prefilled syringe after hysteroscopy surgery Receives: Device: Medicurtain® |
| Placebo | Sham comparator | No device after hysteroscopy surgery Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: comparison between treated group and untreated control group for the adhesion rate
Adhesion rate: {(number of subjects occurred adhesion formation for each group)/ (number of subjects for each group)} * 100
Measured: 4 weeks
Secondary outcomes (4)
Comparison of Adhesion Grade between treated group and untreated control group
Adhesive grade evaluation standards are classified into Grade 0(Non), Grade 1(Mild), Grade 2(Moderate), Grade 3(Severe).
Measured: 4 weeks
The incidence rate of adverse events
Safety and tolerability by collecting adverse events (AEs)
Measured: follow up to 4 weeks
The incidence rate of adverse drug reaction
Safety and tolerability by collecting adverse drug reaction (ADRs)
Measured: follow up to 4 weeks
The incidence rate of serious adverse events
Safety and tolerability by collecting serious adverse events (SAEs)
Measured: follow up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start8 Sep 2010
- Primary completion3 Dec 2011
- Study completion3 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine SynechiaeStudies 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
- Model description
- Pivotal study (Determine effectiveness and adverse effects)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byeongseok Lee, MD, Principal investigator, Gangnam Severance Hospital, 712 Eonju-ro, Gangnam, Seoul, South KoreaYoungsik Choi, MD, Principal investigator, Severance Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul, South KoreaSun Hee Cha, MD, Principal investigator, Bundang CHA Medical Center, 351 Yatap-dong, Seongnam-si, Gyeonggi-do, South KoreaJoomyung Kim, MD, Principal investigator, CHEIL General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, South KoreaKi-Hwan Lee, MD, Principal investigator, Chungnam National University Hospital, 33 Munhwa-ro, Jung-gu, Daejeon, South KoreaIn Taek Hwang, MD, Principal investigator, Daejeon Eulji Medical Center, Dunsan-2-dong, Seo-gu, Daejeon, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638855
- Sponsor's protocol ID
- UMT2009-SP-ASMC-0401
- Status last verified
- Sep 2021
- First submitted
- 16 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
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 Placebo Comparative, Evaluator Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy
- ClinicalTrials.gov ID
- NCT04638855
- Acronym / sponsor ID
- UMT2009-SP-ASMC-0401
- Keywords
- Medicurtain, Sodium hyaluronate, Anti-adhesion barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2010 (actual)
- Primary completion
- 3 Dec 2011 (actual)
- Study completion
- 3 Dec 2011 (actual)
- First posted
- 20 Nov 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, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Adhesion formation in both groups was evaluated by the grading scale and photographs taken during the follow up to evaluate the safety and efficacy of the product.
Detailed description
This study was designed as a multi-center, randomized, evaluator-blinded and placebo-comparative study. A woman aged 20-80 years scheduled for the hysteroscopy was eligible to participate in the study. Subject screening was conducted for the subject who signed an informed consent form. Subjects who met the inclusion/exclusion criteria were randomly assigned into either treatment or no-treatment control group. Follow-up visits were performed at 1 week (Visit 2) and 4 weeks (Visit 3) after the index surgery. Telephone call is made between 1 to 2 weeks prior to the Visit 3 for the information for the follow-up visit and check-up.
At Visit 2 (at Week 1 after the index surgery, a window of ± 2 days was allowed), assessments to identify adverse events and general health conditions, and surgery satisfaction survey were performed. At Visit 3 (at Week 4 ± 4 days), adverse event assessments and general satisfaction survey were performed, and adhesion formations and grades were evaluated. The presence or absence of adhesions, and their grades at Visit 3 (at Week 4 ± 4 days) were assessed in an evaluator-independent manner.
Adhesion formations rate (Primary endpoint) and adhesion grade(secondary endpoint) were assessed at Week 4 after the index surgery (Visit 3), based on the video clips and still images captured via a video monitor during a second-look hysteroscopy, by inserting the hysteroscope (5 -10 mm diameter) into the uterine through the vagina; and graded in an evaluator-blinded manner by an independent evaluator, who did not take part in the index surgery or application of Medicurtain®. Intrauterine adhesion grades were assessed by using the American Fertility Society (AFS) adhesion score established in 1988. It was classified as 4 grading scales (0, 1, 2 and 3 grade). Grade 0 (none) means no adhesion, while Grade 1 to Grade 3 means there are adhesions and severity increased with the grade. Adhesion formation rate and grade in the treated or in the non-treated control groups were compared and evaluated using the Grade 0 to 3 adhesion scoring system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pivotal study (Determine effectiveness and adverse effects)
| Arm | Type | Receives |
|---|---|---|
| Medicurtain® | Experimental | Device: Medicurtain®Treat Medicurtain 5ml prefilled syringe after hysteroscopy surgery |
| Placebo | Sham comparator | Device: PlaceboNo device after hysteroscopy surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Woman who is between 20~80 years of age.
- Woman who is reserved elective hysteroscopy for
- Woman who signed an informed consent form prior to the investigation.
Key exclusion criteria (4 listed)
- Presence of tumor or inflammatory disease in other organs.
- 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 hysteroscopy
- Any condition which made a subject unsuitable for inclusion in the discretion of the Investigator will be excluded.
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 hysteroscopy surgery) | Device | Medicurtain® |
| PlaceboNo device after hysteroscopy surgery | Device | Placebo |
Primary outcome
Outcome Measure: comparison between treated group and untreated control group for the adhesion rate
Time frame: 4 weeks
Adhesion rate: {(number of subjects occurred adhesion formation for each group)/ (number of subjects for each group)} * 100
4 secondary outcomes
Comparison of Adhesion Grade between treated group and untreated control group
Time frame: 4 weeks
The incidence rate of adverse events
Time frame: follow up to 4 weeks
The incidence rate of adverse drug reaction
Time frame: follow up to 4 weeks
The incidence rate of serious adverse events
Time frame: follow up to 4 weeks
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.
- 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.
Byeongseok Lee, MD principal investigator
Gangnam Severance Hospital, 712 Eonju-ro, Gangnam, Seoul, South Korea
Youngsik Choi, MD principal investigator
Severance Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul, South Korea
Sun Hee Cha, MD principal investigator
Bundang CHA Medical Center, 351 Yatap-dong, Seongnam-si, Gyeonggi-do, South 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 Intrauterine Synechiae 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 7 inclusion and 4 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?
Outcome Measure: comparison between treated group and untreated control group for the adhesion rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.