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MIGS-ART: Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

Sponsor
Kern Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06050161
Collaborator
Livs Med (Other)
50
Enrollment
3
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Articulating laparoscopic instrument
  • Device: Conventional laparoscopic instrument
  • Device: Robotic surgical instrument
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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 instrumentThose 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
Masking:
Single (Participant)
Masking Description:
The patient will not be told which surgical approaches were used during surgery
Primary Purpose:
Treatment
Official Title:
Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments
Anticipated Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Sep 20, 2027
Anticipated Study Completion Date :
Sep 20, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Artisential laparoscopic instrument

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Device: Articulating laparoscopic instrument
The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
Other Names:
  • Artisential

    • Device: Conventional laparoscopic instrument
    Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Straight stick laparoscopy

    • Device: Robotic surgical instrument
    Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Da Vinci Robot

    		•
    Active Comparator: Conventional laparoscopic instrument

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

    Device: Articulating laparoscopic instrument
    The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Artisential

    • Device: Conventional laparoscopic instrument
    Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Straight stick laparoscopy

    • Device: Robotic surgical instrument
    Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Da Vinci Robot

    		•
    Active Comparator: Robotic instrument

    Robotic instrument use for suturing during minimally invasive gynecologic surgery

    Device: Articulating laparoscopic instrument
    The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Artisential

    • Device: Conventional laparoscopic instrument
    Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Straight stick laparoscopy

    • Device: Robotic surgical instrument
    Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Other Names:
  • Da Vinci Robot

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mesh suturing time [Intraoperative]

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

    2. Vaginal cuff suturing time [Intraoperative]

      Time to complete closure of the vaginal cuff

    Secondary Outcome Measures

    1. Needling times [Intraoperative]

      Time to pass needle through tissue

    2. Knot tying times [Intraoperative]

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

    3. Knot location [Intraoperative]

      Anterior vs. Posterior knot location

    4. Surgical complications [Intraoperative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kern Medical Center
    • Livs Med

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yufan Chen, Chief, Division of Urogynecology, Department of Obstetrics and Gynecology, Kern Medical Center
    ClinicalTrials.gov Identifier:
    NCT06050161
    Other Study ID Numbers:
    • KM23033
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Yufan Chen, Chief, Division of Urogynecology, Department of Obstetrics and Gynecology, Kern Medical Center
    Laparoscopic surgery
    Laparoscopic suturing
    Laparoscopic instruments
    Pelvic organ prolapse
    Sacrocolpopexy
    Minimally invasive surgery
    Vaginal cuff closure
    Additional relevant MeSH terms:
    Uterine Hemorrhage
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Sep 22, 2023