Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT05151835
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2021-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Robotic Surgical System for Minimally Invasive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-04', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-26', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System', 'timeFrame': '30 days', 'description': 'Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System is defined as the need to change to laparoscopic surgery during the procedure.'}], 'secondaryOutcomes': [{'measure': 'Rate of perioperative complications', 'timeFrame': '30 days', 'description': 'intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification'}, {'measure': 'intraoperative time', 'timeFrame': '30 days', 'description': 'Intraoperative Time'}, {'measure': 'Blood Loss', 'timeFrame': '30 days', 'description': 'Amount of blood loss in mls'}, {'measure': 'Pain scores on a visual analog scale', 'timeFrame': '30 days', 'description': 'Pain score in visual analog scale scoring system (minimum 0 and maxium 10, higher score represents more pain)'}, {'measure': 'Analgesic requirement', 'timeFrame': '30 days', 'description': 'Total dose of analgesic (Pethidine) used'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '30 days', 'description': 'Days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Robotic Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.', 'detailedDescription': 'This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index \\<35 kg/m2\n2. Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases\n3. Willingness to participate as demonstrated by giving informed consent\n\nExclusion Criteria:\n\n1. Contraindication to general anesthesia\n2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention\n3. Untreated active infection\n4. Noncorrectable coagulopathy\n5. Presence of another malignancy or distant metastasis\n6. Emergency surgery\n7. Vulnerable population (e.g. mentally disabled, pregnancy)'}, 'identificationModule': {'nctId': 'NCT05151835', 'acronym': 'K2robo', 'briefTitle': 'Novel Robotic Surgical System for Minimally Invasive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study', 'orgStudyIdInfo': {'id': 'CREC 2021.472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic Surgery', 'description': 'Prospective single arm study to investigate effect of a novel robotic surgical system on safety, efficacy and outcomes for performance of minimally invasive surgery across urology, upper and lower GI surgery.', 'interventionNames': ['Device: K2 Robotic Surgical System']}], 'interventions': [{'name': 'K2 Robotic Surgical System', 'type': 'DEVICE', 'description': 'The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console \\[SGC\\], a Patient Side Robot \\[PSR\\], and a Vision Cart \\[VCT\\], and is used with an endoscope, Surgical Instruments \\[SGI\\], and Accessories \\[ACC\\]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features.', 'armGroupLabels': ['Robotic Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Hong Kong', 'state': 'Outside of US & Canada', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Philip WY Chiu, MD', 'role': 'CONTACT', 'email': 'philipchiu@surgery.cuhk.edu.hk', 'phone': '85235053952'}, {'name': 'Man Yee Yung', 'role': 'CONTACT', 'email': 'myyung@surgery.cuhk.edu.hk', 'phone': '85235052956'}], 'facility': 'Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Philip WY Chiu, MD', 'role': 'CONTACT', 'email': 'philipchiu@surgery.cuhk.edu.hk', 'phone': '+85291252907'}, {'name': 'Man Yee YUNG, RN', 'role': 'CONTACT', 'email': 'myyung@surgery.cuhk.edu.hk', 'phone': '+85235052956'}], 'overallOfficials': [{'name': 'Simon SM Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Philip Wai Yan CHIU', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}