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

Primary Purpose

Pelvic Organ Prolapse, Abnormal Uterine Bleeding, Mesh Augmentation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Articulating laparoscopic instrument
Conventional laparoscopic instrument
Robotic surgical instrument
Sponsored by
Kern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Laparoscopic surgery, Laparoscopic suturing, Laparoscopic instruments, Pelvic organ prolapse, Sacrocolpopexy, Minimally invasive surgery, Vaginal cuff closure

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Artisential laparoscopic instrument

    Conventional laparoscopic instrument

    Robotic instrument

    Arm Description

    Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

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

    Robotic instrument use for suturing during minimally invasive gynecologic surgery

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 17, 2023
    Last Updated
    September 17, 2023
    Sponsor
    Kern Medical Center
    Collaborators
    Livs Med
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06050161
    Brief Title
    Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery
    Acronym
    MIGS-ART
    Official Title
    Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    September 20, 2027 (Anticipated)
    Study Completion Date
    September 20, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kern Medical Center
    Collaborators
    Livs Med

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse, Abnormal Uterine Bleeding, Mesh Augmentation, Laparoscopic Surgery, Robotic Surgical Suturing, Laparoscopic Hysterectomy, Minimally Invasive Surgery
    Keywords
    Laparoscopic surgery, Laparoscopic suturing, Laparoscopic instruments, Pelvic organ prolapse, Sacrocolpopexy, Minimally invasive surgery, Vaginal cuff closure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    Masking
    Participant
    Masking Description
    The patient will not be told which surgical approaches were used during surgery
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Artisential laparoscopic instrument
    Arm Type
    Experimental
    Arm Description
    Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
    Arm Title
    Conventional laparoscopic instrument
    Arm Type
    Active Comparator
    Arm Description
    Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
    Arm Title
    Robotic instrument
    Arm Type
    Active Comparator
    Arm Description
    Robotic instrument use for suturing during minimally invasive gynecologic surgery
    Intervention Type
    Device
    Intervention Name(s)
    Articulating laparoscopic instrument
    Other Intervention Name(s)
    Artisential
    Intervention Description
    The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional laparoscopic instrument
    Other Intervention Name(s)
    Straight stick laparoscopy
    Intervention Description
    Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Intervention Type
    Device
    Intervention Name(s)
    Robotic surgical instrument
    Other Intervention Name(s)
    Da Vinci Robot
    Intervention Description
    Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.
    Primary Outcome Measure Information:
    Title
    Mesh suturing time
    Description
    Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.
    Time Frame
    Intraoperative
    Title
    Vaginal cuff suturing time
    Description
    Time to complete closure of the vaginal cuff
    Time Frame
    Intraoperative
    Secondary Outcome Measure Information:
    Title
    Needling times
    Description
    Time to pass needle through tissue
    Time Frame
    Intraoperative
    Title
    Knot tying times
    Description
    Time to tie a surgeon's knot, followed by 2 square knots
    Time Frame
    Intraoperative
    Title
    Knot location
    Description
    Anterior vs. Posterior knot location
    Time Frame
    Intraoperative
    Title
    Surgical complications
    Description
    List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic)
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female assigned at birth with a uterus
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yufan B Chen, MD
    Phone
    661-326-2000
    Email
    Yufan.Chen@kernmedical.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kayvon Milani
    Phone
    661-326-2673
    Email
    kayvon.milani@kernmedical.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33755941
    Citation
    Darwich I, Abuassi M, Weiss C, Stephan D, Willeke F. The Artisential(R) Articulated Laparoscopic Forceps: A Dry Lab Study to Examine Dexterity and Learning Effects in Operators with Different Levels of Laparoscopic Experience. Surg Technol Int. 2021 May 20;38:29-36. doi: 10.52198/21.STI.38.SO1424.
    Results Reference
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    PubMed Identifier
    33880541
    Citation
    Jung Y, Hong JI, Han KN, Kim HK. Thoracoscopic anterior mediastinal mass removal using an articulating laparoscopic instrument. Interact Cardiovasc Thorac Surg. 2021 Aug 18;33(3):498. doi: 10.1093/icvts/ivab110. No abstract available.
    Results Reference
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    PubMed Identifier
    33854812
    Citation
    Kim A, Lee CM, Park S. Is it Beneficial to Utilize an Articulating Instrument in Single-Port Laparoscopic Gastrectomy? J Gastric Cancer. 2021 Mar;21(1):38-48. doi: 10.5230/jgc.2021.21.e2. Epub 2021 Mar 11.
    Results Reference
    background
    PubMed Identifier
    33275820
    Citation
    Darwich I, Scheidt M, Koliesnikov Y, Willeke F. Laparoscopic low anterior resection performed using ArtiSential(R) in an obese male patient with a narrow pelvis - a video vignette. Colorectal Dis. 2021 Mar;23(3):757-758. doi: 10.1111/codi.15473. Epub 2020 Dec 18. No abstract available.
    Results Reference
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    PubMed Identifier
    33330607
    Citation
    Trevis J, Chilvers N, Freystaetter K, Dunning J. Surgeon-Powered Robotics in Thoracic Surgery; An Era of Surgical Innovation and Its Benefits for the Patient and Beyond. Front Surg. 2020 Nov 26;7:589565. doi: 10.3389/fsurg.2020.589565. eCollection 2020.
    Results Reference
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    PubMed Identifier
    32938322
    Citation
    Kang SH, Won Y, Lee K, Youn SI, Min SH, Park YS, Ahn SH, Kim HH. Single-Incision Proximal Gastrectomy With Double-Flap Esophagogastrostomy Using Novel Laparoscopic Instruments. Surg Innov. 2021 Feb;28(1):151-154. doi: 10.1177/1553350620958237. Epub 2020 Sep 16.
    Results Reference
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    PubMed Identifier
    32926244
    Citation
    Jin HY, Lee CS, Lee YS. Laparoscopic extended right hemicolectomy with D3 lymph node dissection using a new articulating instrument. Tech Coloproctol. 2021 Feb;25(2):235-237. doi: 10.1007/s10151-020-02345-z. Epub 2020 Sep 14. No abstract available.
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    PubMed Identifier
    35601367
    Citation
    Min SH, Cho YS, Park K, Lee Y, Park YS, Ahn SH, Park DJ, Kim HH. Multi-DOF (Degree of Freedom) Articulating Laparoscopic Instrument is an Effective Device in Performing Challenging Sutures. J Minim Invasive Surg. 2019 Dec 15;22(4):157-163. doi: 10.7602/jmis.2019.22.4.157.
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    PubMed Identifier
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    Citation
    Lee CS, Lee YS. Laparoscopic low anterior resection using new articulating instruments. Tech Coloproctol. 2021 Nov;25(11):1259-1261. doi: 10.1007/s10151-021-02486-9. Epub 2021 Jun 17. No abstract available.
    Results Reference
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    PubMed Identifier
    31115696
    Citation
    Kang SH, Cho YS, Min SH, Park YS, Ahn SH, Do Park J, Kim HH. Intracorporeal overlap gastro-gastrostomy for solo single-incision pylorus-preserving gastrectomy in early gastric cancer. Surg Today. 2019 Dec;49(12):1074-1079. doi: 10.1007/s00595-019-01820-x. Epub 2019 May 21.
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    Citation
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    Citation
    Jin HY, Lee CS, Lee YS. Single Incision Laparoscopic Appendectomy Using a New Multi-joint Articulating Instrument. J Gastrointest Surg. 2021 Sep;25(9):2437-2438. doi: 10.1007/s11605-021-05026-w. Epub 2021 May 19. No abstract available.
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    Citation
    Parente G, Thomas E, Cravano S, Di Mitri M, Vastano M, Gargano T, Cerasoli T, Ruspi F, Libri M, Lima M. ArtiSential(R) Articulated Wrist-Like Instruments and Their First Application in Pediatric Minimally Invasive Surgery: Case Reports and Literature Review of the Most Commonly Available Robot-Inspired Devices. Children (Basel). 2021 Jul 17;8(7):603. doi: 10.3390/children8070603.
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    Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

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