Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT04247958
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic 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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2020-01-10', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of SureForm™ Stapler fires and reload colors', 'timeFrame': 'During the procedure', 'description': 'The primary endpoint of the study is to assess the number of fires and reload colors of SureForm™ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.'}], 'secondaryOutcomes': [{'measure': 'Incidence of peri-operative and short term outcomes', 'timeFrame': '30 days post-operative', 'description': 'The secondary endpoint of the study is to assess the incidence of peri-operative and short term outcomes following transection and/or creation of anastomosis using SureForm™ Staplers during robotic-assisted colorectal procedures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Colon Tumor', 'Malignant Colorectal Tumor', 'Benign Colorectal Neoplasm']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.', 'detailedDescription': "This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.\n\nThe study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject undergoing robotic-assisted colorectal procedure for suspected or confirmed benign or malignant colon or rectal disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must be 18 years of age or older at the time of consent\n* Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureForm™Staplers are utilized for transection and/or creation of anastomosis\n\nExclusion Criteria:\n\n* Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy\n* Subject with active bacterial or fungal infection\n* Subject is contraindicated for general anesthesia or surgery\n* Subject is undergoing an emergency procedure\n* Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.\n* Subject has metastatic disease and/or subject has life expectancy of less than 1 year\n* Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure\n* Subject has history of coagulation or hematologic disorder\n* Pregnant or suspect pregnancy\n* The subject is unable to comply with the follow-up visit schedule\n* Subject has perforated, obstructing or locally invasive neoplasm (T4b)\n* Subject with inflammatory bowel disease\n* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent\n* Subject belonging to other vulnerable population, e.g, prisoner or ward of the state\n\nIntra-Operative Exclusion Criteria:\n\n* Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler.\n* Inadequate visualization making an endoscopic approach not feasible\n* Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery'}, 'identificationModule': {'nctId': 'NCT04247958', 'briefTitle': 'A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuitive Surgical'}, 'officialTitle': 'A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures', 'orgStudyIdInfo': {'id': 'ISI-dVCR-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic-assisted colorectal resection', 'description': 'Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum.', 'interventionNames': ['Procedure: Colorectal resection']}], 'interventions': [{'name': 'Colorectal resection', 'type': 'PROCEDURE', 'description': 'Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis.', 'armGroupLabels': ['Robotic-assisted colorectal resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74137', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Surgical Hospital', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}