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

September 17, 2023 updated by: Yufan Chen, Kern Medical Center

Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needling times
Time Frame: Intraoperative
Time to pass needle through tissue
Intraoperative
Knot tying times
Time Frame: Intraoperative
Time to tie a surgeon's knot, followed by 2 square knots
Intraoperative
Knot location
Time Frame: Intraoperative
Anterior vs. Posterior knot location
Intraoperative
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)
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kern Medical Center

Collaborators

Livs Med

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2023

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

September 20, 2027

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM23033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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