Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery (MIGS-ART)

Kern Medical Center

Status: Not yet enrolling

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

Treatments: Device: Conventional laparoscopic instrument; Device: Robotic surgical instrument; Device: Articulating laparoscopic instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT06050161

KM23033

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Artisential laparoscopic instrument

Experimental group

Description:

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Treatment:

Device: Robotic surgical instrument

Device: Articulating laparoscopic instrument

Device: Conventional laparoscopic instrument

Conventional laparoscopic instrument

Active Comparator group

Description:

Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Treatment:

Device: Robotic surgical instrument

Device: Articulating laparoscopic instrument

Device: Conventional laparoscopic instrument

Robotic instrument

Active Comparator group

Description:

Robotic instrument use for suturing during minimally invasive gynecologic surgery

Treatment:

Device: Robotic surgical instrument

Device: Articulating laparoscopic instrument

Device: Conventional laparoscopic instrument