Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-30 @ 4:40 AM
Study NCT ID:
NCT06050161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patient will not be told which surgical approaches were used during surgery'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Those in the study scheduled for a laparoscopic hysterectomy will be randomly selected for the Artisential vs. Robotic vs. Laparoscopic vaginal cuff closure.\n\nThose 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2023-09-17', 'studyFirstSubmitQcDate': '2023-09-17', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mesh suturing time', 'timeFrame': 'Intraoperative', 'description': 'Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.'}, {'measure': 'Vaginal cuff suturing time', 'timeFrame': 'Intraoperative', 'description': 'Time to complete closure of the vaginal cuff'}], 'secondaryOutcomes': [{'measure': 'Needling times', 'timeFrame': 'Intraoperative', 'description': 'Time to pass needle through tissue'}, {'measure': 'Knot tying times', 'timeFrame': 'Intraoperative', 'description': "Time to tie a surgeon's knot, followed by 2 square knots"}, {'measure': 'Knot location', 'timeFrame': 'Intraoperative', 'description': 'Anterior vs. Posterior knot location'}, {'measure': 'Surgical complications', 'timeFrame': 'Intraoperative', 'description': 'List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Laparoscopic surgery', 'Laparoscopic suturing', 'Laparoscopic instruments', 'Pelvic organ prolapse', 'Sacrocolpopexy', 'Minimally invasive surgery', 'Vaginal cuff closure'], 'conditions': ['Pelvic Organ Prolapse', 'Abnormal Uterine Bleeding', 'Mesh Augmentation', 'Laparoscopic Surgery', 'Robotic Surgical Suturing', 'Laparoscopic Hysterectomy', 'Minimally Invasive Surgery']}, 'referencesModule': {'references': [{'pmid': '33755941', 'type': 'BACKGROUND', 'citation': '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': '33880541', 'type': 'BACKGROUND', 'citation': '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': '33854812', 'type': 'BACKGROUND', 'citation': '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': '33275820', 'type': 'BACKGROUND', 'citation': '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': '33330607', 'type': 'BACKGROUND', 'citation': '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': '32938322', 'type': 'BACKGROUND', 'citation': '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': '32926244', 'type': 'BACKGROUND', 'citation': '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': '35601367', 'type': 'BACKGROUND', 'citation': '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': '34142257', 'type': 'BACKGROUND', 'citation': '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': '31115696', 'type': 'BACKGROUND', 'citation': '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': '31032213', 'type': 'BACKGROUND', 'citation': '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': '34013483', 'type': 'BACKGROUND', 'citation': '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': '34356582', 'type': 'BACKGROUND', 'citation': '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': '35601278', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.', 'detailedDescription': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'genderBased': True, 'genderDescription': 'Female assigned at birth with a uterus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for robotic or laparoscopic total hysterectomy\n* Patient scheduled for robotic or laparoscopic sacrocolpopexy\n\nExclusion Criteria:\n\n* Not a candidate for the above surgical procedures'}, 'identificationModule': {'nctId': 'NCT06050161', 'acronym': 'MIGS-ART', 'briefTitle': 'Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kern Medical Center'}, 'officialTitle': 'Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments', 'orgStudyIdInfo': {'id': 'KM23033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artisential laparoscopic instrument', 'description': 'Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery', 'interventionNames': ['Device: Articulating laparoscopic instrument', 'Device: Conventional laparoscopic instrument', 'Device: Robotic surgical instrument']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional laparoscopic instrument', 'description': 'Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery', 'interventionNames': ['Device: Articulating laparoscopic instrument', 'Device: Conventional laparoscopic instrument', 'Device: Robotic surgical instrument']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Robotic instrument', 'description': 'Robotic instrument use for suturing during minimally invasive gynecologic surgery', 'interventionNames': ['Device: Articulating laparoscopic instrument', 'Device: Conventional laparoscopic instrument', 'Device: Robotic surgical instrument']}], 'interventions': [{'name': 'Articulating laparoscopic instrument', 'type': 'DEVICE', 'otherNames': ['Artisential'], 'description': 'The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.', 'armGroupLabels': ['Artisential laparoscopic instrument', 'Conventional laparoscopic instrument', 'Robotic instrument']}, {'name': 'Conventional laparoscopic instrument', 'type': 'DEVICE', 'otherNames': ['Straight stick laparoscopy'], 'description': 'Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.', 'armGroupLabels': ['Artisential laparoscopic instrument', 'Conventional laparoscopic instrument', 'Robotic instrument']}, {'name': 'Robotic surgical instrument', 'type': 'DEVICE', 'otherNames': ['Da Vinci Robot'], 'description': 'Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.', 'armGroupLabels': ['Artisential laparoscopic instrument', 'Conventional laparoscopic instrument', 'Robotic instrument']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yufan B Chen, MD', 'role': 'CONTACT', 'email': 'Yufan.Chen@kernmedical.com', 'phone': '661-326-2000'}, {'name': 'Kayvon Milani', 'role': 'CONTACT', 'email': 'kayvon.milani@kernmedical.com', 'phone': '661-326-2673'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Livs Med', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Urogynecology, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Yufan Chen', 'investigatorAffiliation': 'Kern Medical Center'}}}}