Laparoscopic HysterectomyNCT05645809
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery
A study testing MONOFIX® PGCL and Quill Monoderm™ in people with Laparoscopic Hysterectomy, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- MONOFIX® PGCL and Quill Monoderm™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2022to 30 Sep 2023
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients scheduled for hysterectomy by laparoscopic surgery
- Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator
- Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)
Who cannot join
- Patients with contaminated wounds
- Diseases that may affect wound healing
- When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Jinhwa Hong, +82 2 2626 3149, jhhong93@korea.ac.kr
Jinhwa Hong
About this study
Official title: A Multicenter, Randomized, Single-blinded, Active Controlled, Non-inferiority, Post Marketing Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- MONOFIX® PGCL, Quill Monoderm™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MONOFIX® PGCLDevice
An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.
Quill Monoderm™Device
An absorbable suture made of polyglactin used for soft tissue suture.
| Study group | Role | What they receive |
|---|---|---|
| MONOFIX® PGCL | Experimental | An absorbable suture Receives: Device: MONOFIX® PGCL |
| Quill Monoderm™ | Active comparator | An absorbable suture Receives: Device: Quill Monoderm™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time used for suturing the surgical site during laparoscopic hysterectomy
Time used from when the first suture is started to when the last suture is finished and the suture is cut
Measured: 0Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start3 Nov 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhwa Hong, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645809
- Sponsor's protocol ID
- MF_PGCL_401
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blinded, Active Controlled, Non-inferiority, Post Marketing Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05645809
- Acronym / sponsor ID
- MF_PGCL_401
- Conditions
- Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 12 Dec 2022 (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.
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MONOFIX® PGCL | Experimental | Device: MONOFIX® PGCLAn absorbable suture |
| Quill Monoderm™ | Active comparator | Device: Quill Monoderm™An absorbable suture |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Patients scheduled for hysterectomy by laparoscopic surgery
- Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator
- Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)
Key exclusion criteria (3 listed)
- Patients with contaminated wounds
- Diseases that may affect wound healing
- When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment
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 |
|---|---|---|
| MONOFIX® PGCLAn absorbable suture made of polyglycapron (PGCL) used for soft tissue suture. | Device | MONOFIX® PGCL |
| Quill Monoderm™An absorbable suture made of polyglactin used for soft tissue suture. | Device | Quill Monoderm™ |
Primary outcome
Time used for suturing the surgical site during laparoscopic hysterectomy
Time frame: 0Day
Time used from when the first suture is started to when the last suture is finished and the suture is cut
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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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.
Jinhwa Hong principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MONOFIX® PGCL and Quill Monoderm™ in people with Laparoscopic Hysterectomy, run by Samyang Biopharmaceuticals Corporation 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miryung Jin (+82 2 2157 9961, miryung.jin@samyang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time used for suturing the surgical site during laparoscopic hysterectomy (time frame: 0Day). 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 12 Dec 2022.