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Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06050161
Acronym
MIGS-ART
Enrollment
50
Registered
2023-09-22
Start date
2023-09-20
Completion date
2027-09-20
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Laparoscopic surgery, Laparoscopic suturing, Laparoscopic instruments, Pelvic organ prolapse, Sacrocolpopexy, Minimally invasive surgery, Vaginal cuff closure

Brief 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.

Interventions

DEVICEArticulating laparoscopic instrument

The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.

DEVICEConventional laparoscopic instrument

Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.

DEVICERobotic surgical instrument

Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.

Sponsors

Livs Med
CollaboratorUNKNOWN
Kern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The patient will not be told which surgical approaches were used during surgery

Intervention model description

Those in the study scheduled for a laparoscopic hysterectomy will be randomly selected for the Artisential vs. Robotic vs. Laparoscopic vaginal cuff closure. Those in the study scheduled for sacrocolpopexy will have half the mesh sutured on by the primary surgical approach (robotic or laparoscopic) and the other half sutured on by the Artisential laparoscopic instrument

Eligibility

Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mesh suturing timeIntraoperativeTime to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.
Vaginal cuff suturing timeIntraoperativeTime to complete closure of the vaginal cuff

Secondary

MeasureTime frameDescription
Needling timesIntraoperativeTime to pass needle through tissue
Knot tying timesIntraoperativeTime to tie a surgeon's knot, followed by 2 square knots
Knot locationIntraoperativeAnterior vs. Posterior knot location
Surgical complicationsIntraoperativeList of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic)

Contacts

Primary ContactYufan B Chen, MD
Yufan.Chen@kernmedical.com661-326-2000
Backup ContactKayvon Milani
kayvon.milani@kernmedical.com661-326-2673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026