Benign Gynecologic NeoplasmNCT05629611
Efficacy and Safety Evaluation of Vi-sealer
A study testing Vi-Sealer, Ligasure and Other AHD in people with Benign Gynecologic Neoplasm, run by Hyun Park at 1 site in South Korea.
Trial summary
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Benign Gynecologic Neoplasm
- What is being tested?
- Vi-Sealer, Ligasure and Other AHD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2023to 31 Oct 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 to 65 years
- Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
- Eligible for hysterectomy
- Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure
Who cannot join
- Large uterus size over 16 weeks of gestational age
- Cervical or intraligamentary fibroids
- Severe endometriosis (stage 3 or 4)
- Suspected malignancy of the uterus or adnexa
- Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
- Previous pelvic surgery ≥ 3 times
- Not suitable for laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
Min Jung Kim, +82-031-780-5640, tooncrunch@naver.com
Hyun Park
About this study
Official title: Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.
Read the detailed description
Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.
- Conditions
- Benign Gynecologic Neoplasm
- Being tested
- Vi-Sealer, Ligasure, Other AHD
- Keywords
- Advanced hemostatic devices, Advanced energy devices, Ligasure, Laparoscopic total hysterectomy, Vi-sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-SealerDevice
using Reusable device, Vi-Sealer
LigasureDevice
using Ligasure
Other AHDDevice
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
| Study group | Role | What they receive |
|---|---|---|
| Study 1 Vi-Sealer | Experimental | This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer. Receives: Device: Vi-Sealer |
| Study 1 Ligasure | Active comparator | This group of women undergoing hysterectomy is randomized to the energy device, Ligasure. Receives: Device: Ligasure |
| Study 2 Vi-sealer | Experimental | This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer. Receives: Device: Vi-Sealer |
| Study 2 Other AHD | Active comparator | This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure. Receives: Device: Other AHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative procedure time
Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites
Measured: through study completion, an average of 1 year
Estimated blood loss
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Estimated medical cost of device
Medical costs according to hemostatic instrument use
Measured: within 6 weeks after intervention
Device evaluation score
Ergonomics and subjective hemostatic performances assessed by surgeons using the survey
Measured: through study completion, an average of 1 year
Adverse events
Collect only for adverse events that have a relationship with medical devices for clinical trials
Measured: within 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start20 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Benign Gynecologic NeoplasmStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyun Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyun Park, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629611
- Sponsor's protocol ID
- KGOG4009_Vi-TLH
- Status last verified
- Sep 2024
- First submitted
- 31 Oct 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong C, Goh A, Merkur H. Comparison of surgical outcomes using Gyrus PKS vs LigaSure in total laparoscopic hysterectomy: A randomised controlled trial. Aust N Z J Obstet Gynaecol. 2020 Oct;60(5):790-796. doi: 10.1111/ajo.13217. Epub 2020 Jul 29.
PubMed 32729141Holloran-Schwartz MB, Gavard JA, Martin JC, Blaskiewicz RJ, Yeung PP Jr. Single-Use Energy Sources and Operating Room Time for Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):72-7. doi: 10.1016/j.jmig.2015.08.881. Epub 2015 Aug 28.
PubMed 26318400Janssen PF, Brolmann HA, van Kesteren PJ, Bongers MY, Thurkow AL, Heymans MW, Huirne JA. Perioperative outcomes using LigaSure compared with conventional bipolar instruments in laparoscopic hysterectomy: a randomised controlled trial. BJOG. 2011 Dec;118(13):1568-75. doi: 10.1111/j.1471-0528.2011.03089.x. Epub 2011 Sep 6.
PubMed 21895949Hasanov M, Denschlag D, Seemann E, Gitsch G, Woll J, Klar M. Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial. Arch Gynecol Obstet. 2018 Feb;297(2):409-414. doi: 10.1007/s00404-017-4599-y. Epub 2017 Dec 8.
PubMed 29222641Winter ML, Mendelsohn SA. Total laparoscopic hysterectomy using the harmonic scalpel. JSLS. 1999 Jul-Sep;3(3):185-6.
PubMed 10527328Shiber LJ, Ginn DN, Jan A, Gaskins JT, Biscette SM, Pasic R. Comparison of Industry-Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating ENSEAL versus LigaSure Energy Devices. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):467-473.e1. doi: 10.1016/j.jmig.2017.10.006. Epub 2017 Oct 12.
PubMed 29032252Rothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20.
PubMed 23791399Lee CL, Wu KY, Huang CY, Yen CF. Comparison of LigaSure tissue fusion system and a conventional bipolar device in hysterectomy via natural orifice transluminal endoscopic surgery (NOTES): A randomized controlled trial. Taiwan J Obstet Gynecol. 2019 Jan;58(1):128-132. doi: 10.1016/j.tjog.2018.11.024.
PubMed 30638466Honeck P, Wendt-Nordahl G, Bolenz C, Peters T, Weiss C, Alken P, Michel MS, Hacker A. Hemostatic properties of four devices for partial nephrectomy: a comparative ex vivo study. J Endourol. 2008 May;22(5):1071-6. doi: 10.1089/end.2007.0236.
PubMed 18429683Landman J, Kerbl K, Rehman J, Andreoni C, Humphrey PA, Collyer W, Olweny E, Sundaram C, Clayman RV. Evaluation of a vessel sealing system, bipolar electrosurgery, harmonic scalpel, titanium clips, endoscopic gastrointestinal anastomosis vascular staples and sutures for arterial and venous ligation in a porcine model. J Urol. 2003 Feb;169(2):697-700. doi: 10.1097/01.ju.0000045160.87700.32.
PubMed 12544345Timm RW, Asher RM, Tellio KR, Welling AL, Clymer JW, Amaral JF. Sealing vessels up to 7 mm in diameter solely with ultrasonic technology. Med Devices (Auckl). 2014 Jul 30;7:263-71. doi: 10.2147/MDER.S66848. eCollection 2014.
PubMed 25114600Nieboer TE, Steller CJ, Hinoul P, Maxson AJ, Schwiers ML, Miller CE, Coppus SF, Kent AS. Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:135-9. doi: 10.1016/j.ejogrb.2016.03.035. Epub 2016 Apr 14.
PubMed 27124666Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29.
PubMed 28357561Park JY, Nho J, Cho IJ, Park Y, Kim DY, Suh DS, Kim JH, Nam JH. Laparoendoscopic single-site versus conventional laparoscopic-assisted vaginal hysterectomy for benign or pre-invasive uterine disease. Surg Endosc. 2015 Apr;29(4):890-7. doi: 10.1007/s00464-014-3747-8. Epub 2014 Aug 9.
PubMed 25106721Kim M, Seong SJ, Kim K, Kim SW, Park ST, Kim WY, Choi YJ, Hong DG, Park H. Efficacy and safety evaluation of a reusable advanced hemostatic device (Vi-Sealer) during total laparoscopic hysterectomy in South Korea (KGOG4009/Vi-TLH trial): study protocol for a multicenter, open-label, non-inferiority randomized controlled trial. Trials. 2025 Nov 7;26(1):480. doi: 10.1186/s13063-025-09222-w.
PubMed 41204237
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
- ClinicalTrials.gov ID
- NCT05629611
- Acronym / sponsor ID
- KGOG4009_Vi-TLH
- Conditions
- Benign Gynecologic Neoplasm
- Keywords
- Advanced hemostatic devices, Advanced energy devices, Ligasure, Laparoscopic total hysterectomy, Vi-sealer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hyun ParkUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 29 Nov 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.
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.
Detailed description
Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study 1 Vi-Sealer | Experimental | Device: Vi-SealerThis group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer. |
| Study 1 Ligasure | Active comparator | Device: LigasureThis group of women undergoing hysterectomy is randomized to the energy device, Ligasure. |
| Study 2 Vi-sealer | Experimental | Device: Vi-SealerThis group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer. |
| Study 2 Other AHD | Active comparator | Device: Other AHDThis group of women undergoing hysterectomy is randomized to energy devices other than Ligasure. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20 to 65 years
- Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
- Eligible for hysterectomy
- Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure
Key exclusion criteria (7 listed)
- Large uterus size over 16 weeks of gestational age
- Cervical or intraligamentary fibroids
- Severe endometriosis (stage 3 or 4)
- Suspected malignancy of the uterus or adnexa
- Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
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 |
|---|---|---|
| Vi-Sealerusing Reusable device, Vi-Sealer | Device | Study 1 Vi-Sealer, Study 2 Vi-sealer |
| Ligasureusing Ligasure | Device | Study 1 Ligasure |
| Other AHDUsing other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure | Device | Study 2 Other AHD |
Primary outcome
Operative procedure time
Time frame: through study completion, an average of 1 year
Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites
Estimated blood loss
Time frame: through study completion, an average of 1 year
3 secondary outcomes
Estimated medical cost of device
Time frame: within 6 weeks after intervention
Device evaluation score
Time frame: through study completion, an average of 1 year
Adverse events
Time frame: within 6 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 32729141Wong C, Goh A, Merkur H. Comparison of surgical outcomes using Gyrus PKS vs LigaSure in total laparoscopic hysterectomy: A randomised controlled trial. Aust N Z J Obstet Gynaecol. 2020 Oct;60(5):790-796. doi: 10.1111/ajo.13217. Epub 2020 Jul 29.
- Background: PubMed 26318400Holloran-Schwartz MB, Gavard JA, Martin JC, Blaskiewicz RJ, Yeung PP Jr. Single-Use Energy Sources and Operating Room Time for Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):72-7. doi: 10.1016/j.jmig.2015.08.881. Epub 2015 Aug 28.
- Background: PubMed 21895949Janssen PF, Brolmann HA, van Kesteren PJ, Bongers MY, Thurkow AL, Heymans MW, Huirne JA. Perioperative outcomes using LigaSure compared with conventional bipolar instruments in laparoscopic hysterectomy: a randomised controlled trial. BJOG. 2011 Dec;118(13):1568-75. doi: 10.1111/j.1471-0528.2011.03089.x. Epub 2011 Sep 6.
- Background: PubMed 29222641Hasanov M, Denschlag D, Seemann E, Gitsch G, Woll J, Klar M. Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial. Arch Gynecol Obstet. 2018 Feb;297(2):409-414. doi: 10.1007/s00404-017-4599-y. Epub 2017 Dec 8.
- Background: PubMed 10527328Winter ML, Mendelsohn SA. Total laparoscopic hysterectomy using the harmonic scalpel. JSLS. 1999 Jul-Sep;3(3):185-6.
- Background: PubMed 29032252Shiber LJ, Ginn DN, Jan A, Gaskins JT, Biscette SM, Pasic R. Comparison of Industry-Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating ENSEAL versus LigaSure Energy Devices. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):467-473.e1. doi: 10.1016/j.jmig.2017.10.006. Epub 2017 Oct 12.
- Background: PubMed 23791399Rothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20.
- Background: PubMed 30638466Lee CL, Wu KY, Huang CY, Yen CF. Comparison of LigaSure tissue fusion system and a conventional bipolar device in hysterectomy via natural orifice transluminal endoscopic surgery (NOTES): A randomized controlled trial. Taiwan J Obstet Gynecol. 2019 Jan;58(1):128-132. doi: 10.1016/j.tjog.2018.11.024.
- Background: PubMed 18429683Honeck P, Wendt-Nordahl G, Bolenz C, Peters T, Weiss C, Alken P, Michel MS, Hacker A. Hemostatic properties of four devices for partial nephrectomy: a comparative ex vivo study. J Endourol. 2008 May;22(5):1071-6. doi: 10.1089/end.2007.0236.
- Background: PubMed 12544345Landman J, Kerbl K, Rehman J, Andreoni C, Humphrey PA, Collyer W, Olweny E, Sundaram C, Clayman RV. Evaluation of a vessel sealing system, bipolar electrosurgery, harmonic scalpel, titanium clips, endoscopic gastrointestinal anastomosis vascular staples and sutures for arterial and venous ligation in a porcine model. J Urol. 2003 Feb;169(2):697-700. doi: 10.1097/01.ju.0000045160.87700.32.
- Background: PubMed 25114600Timm RW, Asher RM, Tellio KR, Welling AL, Clymer JW, Amaral JF. Sealing vessels up to 7 mm in diameter solely with ultrasonic technology. Med Devices (Auckl). 2014 Jul 30;7:263-71. doi: 10.2147/MDER.S66848. eCollection 2014.
- Background: PubMed 27124666Nieboer TE, Steller CJ, Hinoul P, Maxson AJ, Schwiers ML, Miller CE, Coppus SF, Kent AS. Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:135-9. doi: 10.1016/j.ejogrb.2016.03.035. Epub 2016 Apr 14.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vi-Sealer, Ligasure and Other AHD in people with Benign Gynecologic Neoplasm, run by Hyun Park 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 4 inclusion and 7 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 1 Oct 2024. 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 Hyun Park (+82-031-780-5640, p06162006@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative procedure time (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT05629611, which also lists 15 linked publications.
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 1 Oct 2024.