Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06915818
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing 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': 65}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Successful Anastomosis Creation without the Need for Reoperation', 'timeFrame': '30 Days', 'description': "The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Colon Anastomosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.', 'detailedDescription': 'This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 22 years or older at screening\n2. Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery\n3. Able to understand and sign informed consent document\n4. American Society of Anesthesiologists (ASA) score \\< IV at time of procedure\n5. All cancer patients must have completed chemotherapy ≥2 months prior to procedure\n6. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study\n7. Able to refrain from smoking during study follow-up period\n\nExclusion Criteria:\n\n1. Known or suspected allergy to silicone, nickel, titanium or Nitinol\n2. BMI \\> 55 kg/m2\n3. Uncontrolled diabetes (defined as HbA1c \\>10%)\n4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet\n5. Diagnosed with obstructed or perforated colon cancer\n6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty during endoscopic delivery of magnets\n7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon\n8. History of recurrent small bowel obstructions.\n9. Coagulation deficiency not normalized by medical treatment or platelet count \\<50,000/µL\n10. Known moderate to severe renal disease (eGFR \\< 44 milliliters per minute per 1.73m2) or ongoing dialysis\n11. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism\n12. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents\n13. Congestive heart failure with ejection fraction \\<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)\n14. Decompensated chronic obstructive lung disease\n15. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.\n16. Contraindication to general anesthesia\n17. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period\n18. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent\n19. Contraindication to general anesthesia\n20. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator'}, 'identificationModule': {'nctId': 'NCT06915818', 'acronym': 'FOCUS', 'briefTitle': 'Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'GI Windows, Inc.'}, 'officialTitle': 'GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures', 'orgStudyIdInfo': {'id': 'GIW 25-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc', 'description': 'This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc.', 'interventionNames': ['Device: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc']}], 'interventions': [{'name': 'Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc', 'type': 'DEVICE', 'description': 'This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.', 'armGroupLabels': ['Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8580000', 'city': 'Santiago', 'state': 'Huechuraba, Región Metropolitana', 'status': 'NOT_YET_RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Pablo Marin, MD', 'role': 'CONTACT', 'email': 'doctorpablomarin@gmail.com', 'phone': '+56982947291'}, {'name': 'Francesca Gorziglia, MD', 'role': 'CONTACT', 'email': 'francesca.gorziglia@gmail.com', 'phone': '+56985007583'}], 'facility': 'Clinica Colonial Hospital', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '454555', 'city': 'Indore', 'state': 'Madhya Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Mohit Bhandari, MD', 'role': 'CONTACT', 'phone': '(+91) 7314231753'}, {'name': 'Mohit Bhandari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vinod Dhakkad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mohak Hitech Specialty Hospital', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}], 'centralContacts': [{'name': 'Peter Lukin', 'role': 'CONTACT', 'email': 'peter.lukin@giwindows.com', 'phone': '+1 7814717901'}], 'overallOfficials': [{'name': 'Mohit Bhandari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mohak Hitech Specialty Hospital'}, {'name': 'Vinod Dhakkad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mohak Hitech Specialty Hospital'}, {'name': 'Pablo Marin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Colonial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GI Windows, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}