Articulating laparoscopic instrument
DeviceThe Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Other names: Artisential
NCT Number: NCT06050161
This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.
Trial opening soon.
Get Notified22 year and older
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Other names: Artisential
Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Other names: Straight stick laparoscopy
Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Other names: Da Vinci Robot
Time frame: Intraoperative
Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.
Time frame: Intraoperative
Time to complete closure of the vaginal cuff
Time frame: Intraoperative
Time to pass needle through tissue
Time frame: Intraoperative
Time to tie a surgeon's knot, followed by 2 square knots
Time frame: Intraoperative
Anterior vs. Posterior knot location
Time frame: Intraoperative
List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic)
Contact information is provided by the study sponsor or research team.
Kayvon Milani
CONTACT
Yufan B Chen, MD
CONTACT
Kern Medical Center
Other
Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments
Acronym: MIGS-ART
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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