NCT06050161

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Sep 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2023Sep 2027

First Submitted

Initial submission to the registry

September 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2027

Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

September 17, 2023

Last Update Submit

September 17, 2023

Conditions

Pelvic Organ ProlapseAbnormal Uterine BleedingMesh AugmentationLaparoscopic SurgeryRobotic Surgical SuturingLaparoscopic HysterectomyMinimally Invasive Surgery

Keywords

Laparoscopic surgeryLaparoscopic suturingLaparoscopic instrumentsPelvic organ prolapseSacrocolpopexyMinimally invasive surgeryVaginal cuff closure

Outcome Measures

Primary Outcomes (2)

  • Mesh suturing time

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

    Intraoperative

  • Vaginal cuff suturing time

    Time to complete closure of the vaginal cuff

    Intraoperative

Secondary Outcomes (4)

  • Needling times

    Intraoperative

  • Knot tying times

    Intraoperative

  • Knot location

    Intraoperative

  • Surgical complications

    Intraoperative

Study Arms (3)

Artisential laparoscopic instrument

EXPERIMENTAL

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

Device: Articulating laparoscopic instrumentDevice: Conventional laparoscopic instrumentDevice: Robotic surgical instrument

Conventional laparoscopic instrument

ACTIVE COMPARATOR

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

Device: Articulating laparoscopic instrumentDevice: Conventional laparoscopic instrumentDevice: Robotic surgical instrument

Robotic instrument

ACTIVE COMPARATOR

Robotic instrument use for suturing during minimally invasive gynecologic surgery

Device: Articulating laparoscopic instrumentDevice: Conventional laparoscopic instrumentDevice: Robotic surgical instrument

Interventions

Articulating laparoscopic instrumentDEVICE

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

Also known as: Artisential
Artisential laparoscopic instrumentConventional laparoscopic instrumentRobotic instrument
Conventional laparoscopic instrumentDEVICE

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

Also known as: Straight stick laparoscopy
Artisential laparoscopic instrumentConventional laparoscopic instrumentRobotic instrument
Robotic surgical instrumentDEVICE

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

Also known as: Da Vinci Robot
Artisential laparoscopic instrumentConventional laparoscopic instrumentRobotic instrument

Eligibility Criteria

Age22 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale assigned at birth with a uterus
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for robotic or laparoscopic total hysterectomy
  • Patient scheduled for robotic or laparoscopic sacrocolpopexy

You may not qualify if:

  • Not a candidate for the above surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 33755941BACKGROUND

  • 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.

    PMID: 33880541BACKGROUND

  • 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.

    PMID: 33854812BACKGROUND

  • 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.

    PMID: 33275820BACKGROUND

  • 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.

    PMID: 33330607BACKGROUND

  • 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.

    PMID: 32938322BACKGROUND

  • 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.

    PMID: 32926244BACKGROUND

  • 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.

    PMID: 35601367BACKGROUND

  • 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.

    PMID: 34142257BACKGROUND

  • 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.

    PMID: 31115696BACKGROUND

  • Dunning J. Disruptive technology will transform what we think of as robotic surgery in under ten years. Ann Cardiothorac Surg. 2019 Mar;8(2):274-278. doi: 10.21037/acs.2019.03.02.

    PMID: 31032213BACKGROUND

  • 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.

    PMID: 34013483BACKGROUND

  • 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.

    PMID: 34356582BACKGROUND

  • Lee E, Lee K, Kang SH, Lee S, Won Y, Park YS, Ahn SH, Suh YS, Kim HH. Usefulness of articulating laparoscopic instruments during laparoscopic gastrectomy for gastric adenocarcinoma. J Minim Invasive Surg. 2021 Mar 15;24(1):35-42. doi: 10.7602/jmis.2021.24.1.35.

    PMID: 35601278BACKGROUND

MeSH Terms

Conditions

Pelvic Organ ProlapseMetrorrhagia

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic Processes

Central Study Contacts

Yufan B Chen, MD

CONTACT

661-326-2000Yufan.Chen@kernmedical.com

Kayvon Milani

CONTACT

661-326-2673kayvon.milani@kernmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient will not be told which surgical approaches were used during surgery
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Urogynecology, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 22, 2023

Study Start

September 20, 2023

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

September 20, 2027

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share