Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT06481605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot, single-center, interventional, prospective case-series study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological anastomotic leaks', 'timeFrame': '90 days after surgery', 'description': 'Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm'}], 'secondaryOutcomes': [{'measure': 'Severity of anastomotic leaks', 'timeFrame': '90 days after surgery', 'description': 'Assess the severity of the anastomotic leaks, classifying the events according to the International Study Group of Rectal Cancer (ISGR) criteria in the C-REX arm'}, {'measure': 'Positive leak tests', 'timeFrame': 'Intraoperative', 'description': 'Assess the rate of intraoperative positive leak tests in the C-REX arm'}, {'measure': 'Positive C-REX integrity tests', 'timeFrame': 'Intraoperative', 'description': 'Assess the rate of intraoperative positive C-REX integrity tests in the C-REX arm'}, {'measure': 'Time of anastomosis construction', 'timeFrame': 'Intraoperative', 'description': 'Assess the median time of anastomosis construction in the C-REX arm'}, {'measure': 'Anastomotic stenosis', 'timeFrame': '90 days after surgery', 'description': 'Assess the rate of anastomosis stenosis, as assessed by the 90-day endoscopic evaluation in the C-REX arm'}, {'measure': 'Postoperative complications', 'timeFrame': '90 days after surgery', 'description': 'Assess the median Comprehensive Complication Index (CCI) in the C-REX arm'}, {'measure': 'Helathcare costs', 'timeFrame': '90 days after surgery', 'description': 'Evaluate the median healthcare costs (direct and indirect) in the C-REX arm'}, {'measure': 'Low Anterior Resection Syndrome', 'timeFrame': '90 days after surgery', 'description': 'Assess the median Low Anterior Resection Syndrome (LARS) score (ranging from 0 to 40, with 21 indicating significant symtpoms) in the C-REX arm.'}, {'measure': "Investigator's satisfaction", 'timeFrame': 'Intraoperative', 'description': "Evaluate the grade of investigator's satisfaction in using the C-REX device by using a simple likert scale ranging from 0 (completely unsatisfaid) to 5 (completely satisfaid)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Neoplasm', 'Anastomosis', 'Surgical device'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.', 'detailedDescription': 'Despite technological advancements, the rate of anastomotic leak after left colon and rectal resection remains high. In most cases, these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes. The device C-REX, developed by CarpoNovum, may help the anastomosis construction, providing at the same time a system to monitor the anastomosis until complete healing. This may lead to reduced anastomotic leak rate and severity. This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial. The objective of the study is to provide preliminary data to determine whether the C-REX device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection, providing new insights on the feasibility and effectiveness of the C-REX device in a real-word setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old, men or women.\n* Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice.\n* Patient indicated to elective minimally invasive sigmoid or high rectal resection.\n\nExclusion Criteria:\n\n* Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.\n* Patients with preoperative evidence of distal metastasis.\n* Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis.\n* Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.\n* Patients indicated to defunctioning ileostomy (intention to treat).\n* Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.'}, 'identificationModule': {'nctId': 'NCT06481605', 'acronym': 'NOVA', 'briefTitle': 'A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study', 'orgStudyIdInfo': {'id': '3902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-REX', 'description': 'Patients will receive the C-REX device during anastomosis construction', 'interventionNames': ['Device: C-REX']}], 'interventions': [{'name': 'C-REX', 'type': 'DEVICE', 'otherNames': ['C-REX RectoAid Cath device'], 'description': 'The C-REX is a CE-marked class IIa device consisting of an invasive surgical part, including two anastomotic rings, intended for short-term use, and surgical instruments LapAid and RectoAid for assisting the placement of the anastomotic ring to intestine. The device is supplemented with a catheter to monitor the anastomosis.', 'armGroupLabels': ['C-REX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'MI', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}, {'name': 'Stefano De Zanet, MS', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 4623', 'phoneExt': '0039'}, {'name': 'Antonino Spinelli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Annalisa Spinelli, PhD', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}, {'name': 'Stefano De Zanet, MS', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'Antonino Spinelli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carponovum AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}