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Clinical Trials/NCT06050161
NCT06050161Not yet recruitingNot Applicable

Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

Kern Medical Center0 sites50 target enrollmentStarted: September 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
Vaginal cuff suturing time

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Artisential laparoscopic instrument

Experimental

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Intervention: Articulating laparoscopic instrument (Device)

Artisential laparoscopic instrument

Experimental

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Intervention: Conventional laparoscopic instrument (Device)

Artisential laparoscopic instrument

Experimental

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Intervention: Robotic surgical instrument (Device)

Conventional laparoscopic instrument

Active Comparator

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

Intervention: Articulating laparoscopic instrument (Device)

Conventional laparoscopic instrument

Active Comparator

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

Intervention: Conventional laparoscopic instrument (Device)

Conventional laparoscopic instrument

Active Comparator

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

Intervention: Robotic surgical instrument (Device)

Robotic instrument

Active Comparator

Robotic instrument use for suturing during minimally invasive gynecologic surgery

Intervention: Articulating laparoscopic instrument (Device)

Robotic instrument

Active Comparator

Robotic instrument use for suturing during minimally invasive gynecologic surgery

Intervention: Conventional laparoscopic instrument (Device)

Robotic instrument

Active Comparator

Robotic instrument use for suturing during minimally invasive gynecologic surgery

Intervention: Robotic surgical instrument (Device)

Outcomes

Primary Outcomes

Vaginal cuff suturing time

Time Frame: Intraoperative

Time to complete closure of the vaginal cuff

Mesh suturing time

Time Frame: Intraoperative

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

Secondary Outcomes

  • Surgical complications(Intraoperative)
  • Knot tying times(Intraoperative)
  • Knot location(Intraoperative)
  • Needling times(Intraoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yufan Chen

Chief, Division of Urogynecology, Department of Obstetrics and Gynecology

Kern Medical Center

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