NCT05629611

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

October 31, 2022

Last Update Submit

September 30, 2024

Conditions

Benign Gynecologic Neoplasm

Keywords

Advanced hemostatic devicesAdvanced energy devicesLigasureLaparoscopic total hysterectomyVi-sealer

Outcome Measures

Primary Outcomes (2)

  • Operative procedure time

    Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites

    through study completion, an average of 1 year

  • Estimated blood loss

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Estimated medical cost of device

    within 6 weeks after intervention

  • Device evaluation score

    through study completion, an average of 1 year

  • Adverse events

    within 6 weeks after intervention

Study Arms (4)

Study 1 Vi-Sealer

EXPERIMENTAL

This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Device: Vi-Sealer

Study 1 Ligasure

ACTIVE COMPARATOR

This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.

Device: Ligasure

Study 2 Vi-sealer

EXPERIMENTAL

This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Device: Vi-Sealer

Study 2 Other AHD

ACTIVE COMPARATOR

This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.

Device: Other AHD

Interventions

Vi-SealerDEVICE

using Reusable device, Vi-Sealer

Study 1 Vi-SealerStudy 2 Vi-sealer
LigasureDEVICE

using Ligasure

Study 1 Ligasure
Other AHDDEVICE

Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Study 2 Other AHD

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Related Publications (15)

  • 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.

    PMID: 32729141BACKGROUND

  • Holloran-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.

    PMID: 26318400BACKGROUND

  • Janssen 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.

    PMID: 21895949BACKGROUND

  • Hasanov 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.

    PMID: 29222641BACKGROUND

  • Winter ML, Mendelsohn SA. Total laparoscopic hysterectomy using the harmonic scalpel. JSLS. 1999 Jul-Sep;3(3):185-6.

    PMID: 10527328BACKGROUND

  • Shiber 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.

    PMID: 29032252BACKGROUND

  • Rothmund 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.

    PMID: 23791399BACKGROUND

  • Lee 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.

    PMID: 30638466BACKGROUND

  • Honeck 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.

    PMID: 18429683BACKGROUND

  • Landman 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.

    PMID: 12544345BACKGROUND

  • Timm 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.

    PMID: 25114600BACKGROUND

  • Nieboer 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.

    PMID: 27124666BACKGROUND

  • Sandberg 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.

    PMID: 28357561BACKGROUND

  • Park 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.

    PMID: 25106721BACKGROUND

  • Kim 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.

    PMID: 41204237DERIVED

Central Study Contacts

Hyun Park

CONTACT

+82-031-780-5640p06162006@cha.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 29, 2022

Study Start

January 20, 2023

Primary Completion

December 1, 2024

Study Completion

October 31, 2025

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)