Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-03-20 @ 1:30 AM
Study NCT ID:
NCT06168669
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigators, clinical teams and subjects will be blinded to the outcomes provided by xBar system. Post operative monitoring will be as per SOC.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All eligible subjects will be assigned with the investigational device.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period.'}, {'measure': 'Safety - Severe leak rate - comparable to SOC.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature.'}, {'measure': 'Performance - successful xBar placement.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The device is working properly and records data in 90% of the cases or more.'}, {'measure': 'Performance - Sensitivity and Specificity of severe leak detection', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sensitivity and Specificity are non-inferior compared to Standard of care at POD 3'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Colorectal Surgery', 'Anastomotic Leak']}, 'descriptionModule': {'briefSummary': 'Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.\n\nThe clinical team is blinded to the leak detection of the xBar system.', 'detailedDescription': "Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.\n\nxBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.\n\nStudy description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 22 years\n2. Indication for sigmoid or rectal resection surgery.\n3. Usage of drain during the surgery (to be confirmed during the surgery)\n4. Willing and able to comply with the study follow up.\n5. Able and agree to provide an informed consent.\n\nExclusion Criteria:\n\n1. Contraindication for surgery and/or general anesthesia.\n2. Pregnancy or lactation.\n3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)\n4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).\n5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.\n6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.\n7. Participation in another interventional study during the xBar system usage.'}, 'identificationModule': {'nctId': 'NCT06168669', 'briefTitle': 'A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exero Medical Ltd.'}, 'officialTitle': 'A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection', 'orgStudyIdInfo': {'id': 'CLP03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Singel arm', 'description': 'All patients will be treated with the investigational device.', 'interventionNames': ['Diagnostic Test: xBar system']}], 'interventions': [{'name': 'xBar system', 'type': 'DIAGNOSTIC_TEST', 'description': 'xBar system is surgical drain with embedded sensors. Collected data will be evaluated for an ability to identify anastomotic leaks. The xBar system does not have therapeutic indication.', 'armGroupLabels': ['Singel arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '328803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'candy.cabrera@adventhealth.com', 'phone': '6032033395'}, {'name': 'Mark Soliman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Robledo', 'role': 'CONTACT', 'email': 'daniel.robledo@adventhealth.com', 'phone': '8136108110'}, {'name': 'Ahmed Allawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sandra Kavalukas, MD', 'role': 'CONTACT'}], 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Craig Reickert, MD', 'role': 'CONTACT'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Micheal Jobst, MD', 'role': 'CONTACT'}], 'facility': 'Bryan Medical Center', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dorna Jaffari, MD', 'role': 'CONTACT'}, {'name': 'Dorna Jaffari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell MC, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Sylla, MD', 'role': 'CONTACT'}], 'facility': 'Mount Sinai Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Martz, MD', 'role': 'CONTACT'}], 'facility': 'Northwell Health, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-8191', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah Nagle, MD', 'role': 'CONTACT'}], 'facility': 'Stony Brook University Hospital and Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Haas, MD', 'role': 'CONTACT', 'email': 'ehaasmd@houstoncolon.com', 'phone': '713-790-0600'}, {'name': 'Eric Haas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HCA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ilya Pinsk, MD', 'role': 'CONTACT'}], 'facility': 'Soroka MC', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ian White, MD', 'role': 'CONTACT'}], 'facility': 'Rabin MC', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Rehovot', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Rafael Miller, MD', 'role': 'CONTACT'}], 'facility': 'Kaplan MC', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}], 'centralContacts': [{'name': 'Ilana Fishman', 'role': 'CONTACT', 'email': 'ilana.fishman@exeromedical.com', 'phone': '+972547545065'}, {'name': 'Erez Shor, PhD', 'role': 'CONTACT', 'email': 'erez.shor@exeromedical.com', 'phone': '+972 54 2600911'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exero Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}