Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT05652361
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system", 'timeFrame': '72 hours after Surgery', 'description': "System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action"}], 'secondaryOutcomes': [{'measure': 'Operating time [min]', 'timeFrame': 'During Surgery', 'description': 'Time from skin incision until placement of last skin staple/suture'}, {'measure': 'Duration of postoperative hospital stay [days]', 'timeFrame': 'At day of discharge, assessed up to 90 days', 'description': 'Postoperative day 1 until day of discharge'}, {'measure': 'Duration of postoperative intermediate/intensive care unit stay [days]', 'timeFrame': 'At day of discharge, assessed up to 90 days', 'description': 'Postoperative day 1 until day of discharge'}, {'measure': 'Assessment of pelvic function before and after rectal resection', 'timeFrame': '24 months', 'description': 'Rectal and urogenital function will be assessed preoperatively and 12-24 months postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).'}, {'measure': 'Rectal sphincter function before and after rectal resection', 'timeFrame': '24 months', 'description': 'Sphincter function will be assessed by manometry preoperatively and 12 - 24 months postoperatively'}, {'measure': 'Frequency of peri-operative morbidity after resection', 'timeFrame': '24 months', 'description': 'Frequency of peri-operative complications after surgery'}, {'measure': 'Kind of peri-operative morbidity after resection', 'timeFrame': '24 months', 'description': 'Kind of peri-operative complications after surgery'}, {'measure': 'Assessment of usability of guidance system', 'timeFrame': '48 hours after surgery', 'description': 'Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually'}, {'measure': 'Assessment of the difficulty of the preparation', 'timeFrame': '48 hours after surgery', 'description': 'Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually'}, {'measure': 'Assessment of oncological outcomes: Frequency of Overall survival (OS)', 'timeFrame': '24 months', 'description': 'The overall survival of all patients is assessed between operation date to date of death of any cause'}, {'measure': 'Assessment of oncological outcomes: Frequency of Progression Free survival (PFS)', 'timeFrame': '24 months', 'description': 'The progression free survival of all patients is assessed between operation date to date of tumor progression'}, {'measure': 'Assessment of oncological outcomes: Frequency of Loco-Regional Tumor Free Survival (LRFS)', 'timeFrame': '24 months', 'description': 'The Loco-Regional Tumor Free Survival of all patients is assessed between operation date to date of local tumor relapse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic Surgery', 'Total mesorectal excision'], 'conditions': ['Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with rectal cancer scheduled for robot-assisted rectal resection\n* Intact preoperative urogenital/rectal function\n* Full capability of consent\n\nExclusion Criteria:\n\n* Previous/Second malignant disease \\<5 years before diagnosis of rectal cancer\n* Previous abdominal surgery, except for appendectomy, cholecystectomy or Cesarean section'}, 'identificationModule': {'nctId': 'NCT05652361', 'acronym': 'CoBot2', 'briefTitle': 'Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study', 'orgStudyIdInfo': {'id': 'VTG-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional visualisation of surgical assistance during surgery', 'interventionNames': ['Other: Additional visualisation of surgical assistance during surgery']}], 'interventions': [{'name': 'Additional visualisation of surgical assistance during surgery', 'type': 'OTHER', 'description': 'Robot-assisted anterior rectal resection using daVinci® system as CE-marked gold standard with additional visualization of surgical assistance functions based on machine learning techniques', 'armGroupLabels': ['Additional visualisation of surgical assistance during surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marius Distler, Prof. Dr.', 'role': 'CONTACT', 'email': 'marius.distler@ukdd.de'}], 'facility': 'Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Marius Distler, Prof. Dr.', 'role': 'CONTACT', 'email': 'marius.distler@ukdd.de', 'phone': '+49 351 458 4098'}, {'name': 'Fiona Kolbinger, Dr.', 'role': 'CONTACT', 'email': 'fiona.kolbinger@ukdd.de', 'phone': '+49 351 458 4098'}], 'overallOfficials': [{'name': 'Marius Distler, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Carl Gustav Carus Dresden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}