An interventional study of Articulating laparoscopic instrument and Conventional laparoscopic instrument in Pelvic Organ Prolapse, Abnormal Uterine Bleeding and Mesh Augmentation, sponsored by Kern Medical Center. Not yet recruiting. Open to female participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Kern Medical Center · Not applicable, Interventional, and Treatment
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.
516 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 334 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Kern Medical Center is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Device: Articulating laparoscopic instrument · Device: Conventional laparoscopic instrument · Device: Robotic surgical instrument
Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Device: Articulating laparoscopic instrument · Device: Conventional laparoscopic instrument · Device: Robotic surgical instrument
Robotic instrument use for suturing during minimally invasive gynecologic surgery
Device: Articulating laparoscopic instrument · Device: Conventional laparoscopic instrument · Device: Robotic surgical instrument
The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Also known as: Artisential
Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Also known as: Straight stick laparoscopy
Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Also known as: Da Vinci Robot
Mesh suturing time
Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.
Time frame: Intraoperative
Vaginal cuff suturing time
Time to complete closure of the vaginal cuff
Time frame: Intraoperative
Needling times
Time to pass needle through tissue
Time frame: Intraoperative
Knot tying times
Time to tie a surgeon's knot, followed by 2 square knots
Time frame: Intraoperative
Knot location
Anterior vs. Posterior knot location
Time frame: Intraoperative
Surgical complications
List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic)
Time frame: Intraoperative
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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