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Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments
This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.
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.
Age
22 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Start Date
September 20, 2023
Primary Completion Date
September 20, 2027
Completion Date
September 20, 2027
Last Updated
September 22, 2023
50
ESTIMATED participants
Articulating laparoscopic instrument
DEVICE
Conventional laparoscopic instrument
DEVICE
Robotic surgical instrument
DEVICE
Lead Sponsor
Kern Medical Center
Collaborators
NCT05602246
NCT06024109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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