Efficacy and Safety Evaluation of Vi-sealer

Benign Gynecologic Neoplasm Clinical Trial

Official title:

Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629611
• Other study ID #: KGOG4009_Vi-TLH
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: CHA University
• Contact: Hyun Park
• Phone: +82-031-780-5640
• Email: p06162006[@]cha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 31, 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Gynecologic Neoplasm
• Genital Neoplasms, Female

Intervention

Device:
• Vi-Sealer
using Reusable device, Vi-Sealer
• Ligasure
using Ligasure
• Other AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hyun Park

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Estimated blood loss		through study completion, an average of 1 year
Secondary	Estimated medical cost of device	Medical costs according to hemostatic instrument use	within 6 weeks after intervention
Secondary	Device evaluation score	Ergonomics and subjective hemostatic performances assessed by surgeons using the survey	through study completion, an average of 1 year
Secondary	Adverse events	Collect only for adverse events that have a relationship with medical devices for clinical trials	within 6 weeks after intervention