Clinical trial · Interventional
Efficacy and Safety Evaluation of Vi-sealer
Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
NCT05629611CI-TRIAL-00081204recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Gynecologic Neoplasm | Benign Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ligasure | Device | — | UNRESOLVED |
| Other AHD | Device | — | UNRESOLVED |
| Vi-Sealer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Study 1 Vi-Sealer
- description
- This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
- interventionNames
- Device: Vi-Sealer
- type
- ACTIVE_COMPARATOR
- label
- Study 1 Ligasure
- description
- This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.
- interventionNames
- Device: Ligasure
- type
- EXPERIMENTAL
- label
- Study 2 Vi-sealer
- description
- This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 20 to 65 years 2. Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.) 3. Eligible for hysterectomy 4. 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 Exclusion Criteria: 1. Large uterus size over 16 weeks of gestational age 2. Cervical or intraligamentary fibroids 3. Severe endometriosis (stage 3 or 4) 4. Suspected malignancy of the uterus or adnexa 5. Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers) 6. Previous pelvic surgery ≥ 3 times 7. Not suitable for laparoscopic surgery
References
Publications (15)
- BACKGROUNDWong 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 32729141
- BACKGROUNDHolloran-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 26318400
- BACKGROUNDJanssen 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 21895949
- BACKGROUNDHasanov 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 29222641
- BACKGROUNDWinter ML, Mendelsohn SA. Total laparoscopic hysterectomy using the harmonic scalpel. JSLS. 1999 Jul-Sep;3(3):185-6. PMID 10527328
- BACKGROUNDShiber 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 29032252
- BACKGROUNDRothmund 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.