Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT03306966
Status:
WITHDRAWN
Last Update Posted:
2018-06-01
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
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': 0}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Design modification', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2017-10-06', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events related to the index-procedure.', 'timeFrame': '3 to 4 weeks follow-up', 'description': 'Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.'}, {'measure': 'Number of patients with adverse events related to the index-procedure.', 'timeFrame': '3 months follow-up', 'description': 'Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.'}, {'measure': 'Number of patients with adverse events related to the index-procedure.', 'timeFrame': '6 months follow-up', 'description': 'Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.'}], 'secondaryOutcomes': [{'measure': 'Number of adverse device effects.', 'timeFrame': '3 to 4 weeks follow-up', 'description': 'Determination of the sharpness of the blade and occurrence of disruption of the staple line.'}, {'measure': 'Number of adverse device effects.', 'timeFrame': '3 months follow-up', 'description': 'Determination of the sharpness of the blade and occurrence of disruption of the staple line.'}, {'measure': 'Number of adverse device effects.', 'timeFrame': '6 months follow-up', 'description': 'Determination of the sharpness of the blade and occurrence of disruption of the staple line.'}, {'measure': 'Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.', 'timeFrame': '3 to 4 weeks follow-up'}, {'measure': 'Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.', 'timeFrame': '3 months follow-up'}, {'measure': 'Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.', 'timeFrame': '6 months follow-up'}, {'measure': 'Number of patients with colectomy related re-interventions.', 'timeFrame': '3 to 4 weeks follow-up'}, {'measure': 'Number of patients with colectomy related re-interventions.', 'timeFrame': '3 months follow-up'}, {'measure': 'Number of patients with colectomy related re-interventions.', 'timeFrame': '6 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ascending colon'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to evaluate the safety and performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the ascending colon. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age at study entry is at least 18 years.\n* Patient must sign and date the informed consent form prior to the index-procedure.\n* Patient has a tumor in the ascending colon.\n\nExclusion Criteria:\n\n* Patient is pregnant.\n* Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease).\n* Patient has symptomatic diverticulitis.\n* Patient has bowel trauma.\n* Patient has peritoneal carcinomatosis.\n* Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits."}, 'identificationModule': {'nctId': 'NCT03306966', 'briefTitle': 'Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Duomed'}, 'officialTitle': 'Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study', 'orgStudyIdInfo': {'id': 'ST-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colon cancer patients', 'description': 'Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.', 'interventionNames': ['Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)']}], 'interventions': [{'name': 'Endoscopic Linear Cutter Stapler and Reloads (Frankenman)', 'type': 'DEVICE', 'description': 'The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.', 'armGroupLabels': ['Colon cancer patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kurt Van Der Speeten, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZOL, Genk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}