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Pelvic Organ ProlapseMIGS-ARTNCT06050161

Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

A study testing Articulating laparoscopic instrument, Conventional laparoscopic instrument and Robotic surgical instrument in people with Pelvic Organ Prolapse and Abnormal Uterine Bleeding, run by Kern Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 22 years and older, women onlyHealthy volunteers can take part
What is being tested?
Articulating laparoscopic instrument, Conventional laparoscopic instrument and Robotic surgical instrument
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
20 Sep 2023to 20 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Not a candidate for the above surgical procedures

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yufan B Chen, MD contact

661-326-2000

Yufan.Chen@kernmedical.com

Kayvon Milani contact

661-326-2673

kayvon.milani@kernmedical.com

About this study

Official title: 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.

Read the 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.

Being tested
Articulating laparoscopic instrument, Conventional laparoscopic instrument, Robotic surgical instrument
Keywords
Laparoscopic surgery, Laparoscopic suturing, Laparoscopic instruments, Pelvic organ prolapse, Sacrocolpopexy, Minimally invasive surgery, Vaginal cuff closure
Medical subject headings
Pelvic Organ Prolapse, Metrorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Articulating laparoscopic instrumentDevice

    Also called Artisential

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

  • Conventional laparoscopic instrumentDevice

    Also called Straight stick laparoscopy

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

  • Robotic surgical instrumentDevice

    Also called Da Vinci Robot

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

Study groups in NCT06050161
Study groupRoleWhat they receive
Artisential laparoscopic instrumentExperimentalArtisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Receives: Device: Articulating laparoscopic instrument; Device: Conventional laparoscopic instrument; Device: Robotic surgical instrument
Conventional laparoscopic instrumentActive comparatorConventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Receives: Device: Articulating laparoscopic instrument; Device: Conventional laparoscopic instrument; Device: Robotic surgical instrument
Robotic instrumentActive comparatorRobotic instrument use for suturing during minimally invasive gynecologic surgery
Receives: Device: Articulating laparoscopic instrument; Device: Conventional laparoscopic instrument; Device: Robotic surgical instrument

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mesh suturing time

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

    Measured: Intraoperative

  2. Vaginal cuff suturing time

    Time to complete closure of the vaginal cuff

    Measured: Intraoperative

Secondary outcomes (4)

  1. Needling times

    Time to pass needle through tissue

    Measured: Intraoperative

  2. Knot tying times

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

    Measured: Intraoperative

  3. Knot location

    Anterior vs. Posterior knot location

    Measured: Intraoperative

  4. Surgical complications

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

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start20 Sep 2023 (estimated)
  3. Primary completion20 Sep 2027 (estimated)
  4. Study completion20 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050161
Sponsor's protocol ID
KM23033
Acronym
MIGS-ART
Status last verified
Sep 2023
First submitted
17 Sep 2023
Last updated
22 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 33755941

  • 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.

    PubMed 33880541

  • 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.

    PubMed 33854812

  • 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.

    PubMed 33275820

  • 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.

    PubMed 33330607

  • 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.

    PubMed 32938322

  • 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.

    PubMed 32926244

  • 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.

    PubMed 35601367

  • 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.

    PubMed 34142257

  • 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.

    PubMed 31115696

  • 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.

    PubMed 31032213

  • 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.

    PubMed 34013483

  • 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.

    PubMed 34356582

  • 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.

    PubMed 35601278

Questions about this trial

What is this clinical trial studying?

A study testing Articulating laparoscopic instrument, Conventional laparoscopic instrument and Robotic surgical instrument in people with Pelvic Organ Prolapse and Abnormal Uterine Bleeding, run by Kern Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yufan B Chen, MD (661-326-2000, Yufan.Chen@kernmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mesh suturing time (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06050161, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.

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