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NCT06050161 Clinical Trial

Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

Pelvic Organ Prolapse Clinical Trial

— MIGS-ART  

Official title:
Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06050161
Other study ID # KM23033
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 20, 2023
Est. completion date September 20, 2027

Study information
Verified date September 2023
Source Kern Medical Center
Contact Yufan B Chen, MD
Phone 661-326-2000
Email Yufan.Chen@kernmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.

Description:

The Artisential laparoscopic instrument is a novel device that allows multi-directional articulation during laparoscopic surgery. There are currently no studies evaluating the efficacy or safety of this device in minimally invasive gynecologic surgery. The investigators aim to compare the efficacy and safety of the Artisential instrument with conventional laparoscopic or robotic instruments. Patients who are scheduled for a laparoscopic or robotic hysterectomy and/or laparoscopic or robotic sacrocolpopexy will be invited to participate in this study. During the suturing portion of the surgery (either vaginal cuff closure during a hysterectomy, or mesh attachment during a sacrocolpopexy), operating times and safety outcomes will be measured. The approach for vaginal cuff closure will be randomly selected. The approach for mesh attachment suturing will be based on the primary surgical approach (conventional laparoscopy or robotic) and compared to suturing with the Artisential and an internally controlled environment. Therefore, half of the knots placed during a case will be with the Artisential laparoscopic device, and the other half will be placed either with robotic instruments or conventional laparoscopic instruments.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 20, 2027
Est. primary completion date September 20, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 22 Years and older
Eligibility Inclusion Criteria: - Patient scheduled for robotic or laparoscopic total hysterectomy - Patient scheduled for robotic or laparoscopic sacrocolpopexy Exclusion Criteria: - Not a candidate for the above surgical procedures

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Articulating laparoscopic instrument
The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
• Conventional laparoscopic instrument
Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
• Robotic surgical instrument
Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Kern Medical Center Livs Med

References & Publications (14)

Darwich I, Abuassi M, Weiss C, Stephan D, Willeke F. The Artisential(R) Articulated Laparoscopic Forceps: A Dry Lab Study to Examine Dexterity and Learning Effects in Operators with Different Levels of Laparoscopic Experience. Surg Technol Int. 2021 May 20;38:29-36. doi: 10.52198/21.STI.38.SO1424. — View Citation

Darwich I, Scheidt M, Koliesnikov Y, Willeke F. Laparoscopic low anterior resection performed using ArtiSential(R) in an obese male patient with a narrow pelvis - a video vignette. Colorectal Dis. 2021 Mar;23(3):757-758. doi: 10.1111/codi.15473. Epub 2020 Dec 18. No abstract available. — View Citation

Dunning J. Disruptive technology will transform what we think of as robotic surgery in under ten years. Ann Cardiothorac Surg. 2019 Mar;8(2):274-278. doi: 10.21037/acs.2019.03.02. — View Citation

Jin HY, Lee CS, Lee YS. Laparoscopic extended right hemicolectomy with D3 lymph node dissection using a new articulating instrument. Tech Coloproctol. 2021 Feb;25(2):235-237. doi: 10.1007/s10151-020-02345-z. Epub 2020 Sep 14. No abstract available. — View Citation

Jin HY, Lee CS, Lee YS. Single Incision Laparoscopic Appendectomy Using a New Multi-joint Articulating Instrument. J Gastrointest Surg. 2021 Sep;25(9):2437-2438. doi: 10.1007/s11605-021-05026-w. Epub 2021 May 19. No abstract available. — View Citation

Jung Y, Hong JI, Han KN, Kim HK. Thoracoscopic anterior mediastinal mass removal using an articulating laparoscopic instrument. Interact Cardiovasc Thorac Surg. 2021 Aug 18;33(3):498. doi: 10.1093/icvts/ivab110. No abstract available. — View Citation

Kang SH, Cho YS, Min SH, Park YS, Ahn SH, Do Park J, Kim HH. Intracorporeal overlap gastro-gastrostomy for solo single-incision pylorus-preserving gastrectomy in early gastric cancer. Surg Today. 2019 Dec;49(12):1074-1079. doi: 10.1007/s00595-019-01820-x. Epub 2019 May 21. — View Citation

Kang SH, Won Y, Lee K, Youn SI, Min SH, Park YS, Ahn SH, Kim HH. Single-Incision Proximal Gastrectomy With Double-Flap Esophagogastrostomy Using Novel Laparoscopic Instruments. Surg Innov. 2021 Feb;28(1):151-154. doi: 10.1177/1553350620958237. Epub 2020 Sep 16. — View Citation

Kim A, Lee CM, Park S. Is it Beneficial to Utilize an Articulating Instrument in Single-Port Laparoscopic Gastrectomy? J Gastric Cancer. 2021 Mar;21(1):38-48. doi: 10.5230/jgc.2021.21.e2. Epub 2021 Mar 11. — View Citation

Lee CS, Lee YS. Laparoscopic low anterior resection using new articulating instruments. Tech Coloproctol. 2021 Nov;25(11):1259-1261. doi: 10.1007/s10151-021-02486-9. Epub 2021 Jun 17. No abstract available. — View Citation

Lee E, Lee K, Kang SH, Lee S, Won Y, Park YS, Ahn SH, Suh YS, Kim HH. Usefulness of articulating laparoscopic instruments during laparoscopic gastrectomy for gastric adenocarcinoma. J Minim Invasive Surg. 2021 Mar 15;24(1):35-42. doi: 10.7602/jmis.2021.24.1.35. — View Citation

Min SH, Cho YS, Park K, Lee Y, Park YS, Ahn SH, Park DJ, Kim HH. Multi-DOF (Degree of Freedom) Articulating Laparoscopic Instrument is an Effective Device in Performing Challenging Sutures. J Minim Invasive Surg. 2019 Dec 15;22(4):157-163. doi: 10.7602/jmis.2019.22.4.157. — View Citation

Parente G, Thomas E, Cravano S, Di Mitri M, Vastano M, Gargano T, Cerasoli T, Ruspi F, Libri M, Lima M. ArtiSential(R) Articulated Wrist-Like Instruments and Their First Application in Pediatric Minimally Invasive Surgery: Case Reports and Literature Review of the Most Commonly Available Robot-Inspired Devices. Children (Basel). 2021 Jul 17;8(7):603. doi: 10.3390/children8070603. — View Citation

Trevis J, Chilvers N, Freystaetter K, Dunning J. Surgeon-Powered Robotics in Thoracic Surgery; An Era of Surgical Innovation and Its Benefits for the Patient and Beyond. Front Surg. 2020 Nov 26;7:589565. doi: 10.3389/fsurg.2020.589565. eCollection 2020. — View Citation

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

Outcome
Type Measure Description Time frame Safety issue
Primary Mesh suturing time Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times. Intraoperative
Primary Vaginal cuff suturing time Time to complete closure of the vaginal cuff Intraoperative
Secondary Needling times Time to pass needle through tissue Intraoperative
Secondary Knot tying times Time to tie a surgeon's knot, followed by 2 square knots Intraoperative
Secondary Knot location Anterior vs. Posterior knot location Intraoperative
Secondary Surgical complications List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic) Intraoperative
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