NCT06050161

Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kern Medical Center · Academic / Other
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pelvic Organ Prolapse
• Abnormal Uterine Bleeding
• Mesh Augmentation
• Laparoscopic Surgery
• Robotic Surgical Suturing
• Laparoscopic Hysterectomy
• Minimally Invasive Surgery

Interventions

Type	Name	Description
DEVICE	Articulating laparoscopic instrument	The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
DEVICE	Conventional laparoscopic instrument	Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
DEVICE	Robotic surgical instrument	Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.

Timeline

• Start date: 2023-09-20
• Primary completion: 2027-09-20
• Completion: 2027-09-20
• First posted: 2023-09-22
• Last updated: 2023-09-22

Regulatory

• FDA-regulated device study