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Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

ConditionsPelvic Organ ProlapseAbnormal Uterine BleedingMesh AugmentationLaparoscopic SurgeryRobotic Surgical SuturingLaparoscopic HysterectomyMinimally Invasive Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorKern Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient scheduled for robotic or laparoscopic total hysterectomy

Patient scheduled for robotic or laparoscopic sacrocolpopexy

Disqualifiers

Not a candidate for the above surgical procedures

Trial design

Design model

Crossover

Treatments tested in this trial

  • Articulating laparoscopic instrument

    Device

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

  • Conventional laparoscopic instrument

    Device

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

  • Robotic surgical instrument

    Device

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

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Artisential laparoscopic instrumentExperimental treatment 3 interventions
Group B: Conventional laparoscopic instrumentActive comparator 3 interventions
Group C: Robotic instrumentActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Mesh suturing time

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

Time frame
Intraoperative
2

Vaginal cuff suturing time

Time to complete closure of the vaginal cuff

Time frame
Intraoperative

Secondary outcomes

1

Needling times

Time to pass needle through tissue

Time frame
Intraoperative
2

Knot tying times

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

Time frame
Intraoperative
3

Knot location

Anterior vs. Posterior knot location

Time frame
Intraoperative
4

Surgical complications

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

Time frame
Intraoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kern Medical Center

Lead sponsor

Livs Med

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: