Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06050161

Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Articulating laparoscopic instrument

Device

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

Other names: Artisential

Conventional laparoscopic instrument

Device

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

Other names: Straight stick laparoscopy

Robotic surgical instrument

Device

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

Other names: Da Vinci Robot

Primary outcomes

  1. Mesh suturing time

    Time frame: Intraoperative

    Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.

  2. Vaginal cuff suturing time

    Time frame: Intraoperative

    Time to complete closure of the vaginal cuff

Secondary outcomes

  1. Needling times

    Time frame: Intraoperative

    Time to pass needle through tissue

  2. Knot tying times

    Time frame: Intraoperative

    Time to tie a surgeon's knot, followed by 2 square knots

  3. Knot location

    Time frame: Intraoperative

    Anterior vs. Posterior knot location

  4. Surgical complications

    Time frame: Intraoperative

    List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic)

Study contacts

Contact information is provided by the study sponsor or research team.

Kayvon Milani

CONTACT

[email protected]

661-326-2673

Yufan B Chen, MD

CONTACT

[email protected]

661-326-2000

Sponsors and collaborators

Lead sponsor

Kern Medical Center

Other

Collaborators

  • Livs Med

Registry information

Official study title

Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

Acronym: MIGS-ART

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.