Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-29 @ 3:35 AM
Study NCT ID:
NCT06935734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours', 'timeFrame': '48 hours', 'description': 'Absence of Major Adverse Events (MAEs) within 48 hours of the procedure. MAEs are defined as any of the following:\n\n1. Device-related death within 48 hours\n2. Perforation within 48 hours\n3. Intraprocedural bleeding preventing completion of the procedure\n4. Delayed bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop of \\>2 g, leading to admission to the hospital, prolongation of hospital stay, or another procedure requiring sedation/anesthesia.\n\nUnit of Measure: Number of participants with at least one Major Adverse Event'}, {'measure': 'Efficacy Endpoint - Successful Completion of Colonoscopy', 'timeFrame': 'During procedure', 'description': 'Completion of colonoscopy defined by both: (a) successful cecal intubation (clinically acceptable access and visualization of the cecum), and (b) successful withdrawal (clinically acceptable diagnostic and therapeutic access of the entire colon tract).'}], 'secondaryOutcomes': [{'measure': 'Time to Cecum', 'timeFrame': 'During procedure', 'description': 'Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes'}, {'measure': 'Need for Repositioning', 'timeFrame': 'During procedure', 'description': 'Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events'}, {'measure': 'Polypectomy Success', 'timeFrame': 'During procedure', 'description': 'If applicable, indicates whether at least one polyp was successfully removed using standard polypectomy tools during the procedure. This outcome is evaluated per participant and applies only to Phase B (robotic procedures).\n\nUnit of Measure: Categorical - Yes / No / Partial (i.e., at least one polyp removed, but not all targeted polyps).'}, {'measure': 'NASA Task Load Index (NASA-TLX)', 'timeFrame': 'Post-procedure', 'description': "Physician's subjective workload assessment using the NASA Task Load Index (NASA-TLX), a validated tool consisting of six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored from 0 to 100 in increments of 5. Higher scores indicate greater perceived workload.\n\nUnit of Measure: Composite score (0-100)"}, {'measure': 'Mucosal Injury Score', 'timeFrame': 'During procedure', 'description': 'Mucosal injury graded using a 5-point ordinal scale based on injury severity: 1 = Erythema/ Bruising, 2 = Mucosal break \\<5mm in length, 3 = Mucosal break \\>5mm in length, 4 = Mucosal Injury (non-full thickness), 5 = Full thickness injury. Outcome is reported per subject. Only applicable to Phase B (robotic procedures).\n\nUnit of Measure: Score (1-5); higher scores indicate more severe injury'}, {'measure': 'Delayed Bleeding (14 Days)', 'timeFrame': '14 days', 'description': 'Number of participants with delayed bleeding within 14 days confirmed by pre-determined symptoms and hemoglobin drop of \\>2 g/dL.\n\nUnit of Measure: Number of participants'}, {'measure': 'Delayed Perforation (14 Days)', 'timeFrame': '14 days', 'description': 'Number of participants with delayed perforation identified within 14 days post-procedure.\n\nUnit of Measure: Number of participants'}, {'measure': 'Adenoma Detection Rate (ADR)', 'timeFrame': 'During procedure', 'description': 'Proportion of participants in whom at least one adenomatous polyp is detected during the robotic colonoscopy procedure. Applicable to Phase B (robotic procedures) only.\n\nUnit of Measure: Percentage of participants with ≥1 adenoma detected'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonoscopy', 'Colorectal Cancer Screening', 'Colorectal Neoplasms', 'Gastrointestinal Endoscopy']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Age ≥ 22 years\n2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy\n3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan specific procedures\n4. Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -\n\nExclusion Criteria:\n\nInitial Screening / Pre-Operative:\n\n1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.\n2. Any active implantable medical devices (e.g., pacemakers, defibrillators)\n3. Previous failed colonoscopy (except for inadequate bowel preparation)\n4. BMI \\> 45 kg/m2\n5. Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).\n6. Surgically altered colonic anatomy\n7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon\n8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day\n9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies\n10. Patient receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin\n11. Known colonic stricture\n12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment\n13. Known abdominal wall hernias\n14. History of radiotherapy to the abdomen or pelvis\n15. History of mesenteric ischemia\n16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure\n17. Contraindication to the proposed sedation / anesthesia\n18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure\n19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure\n20. Participation in any concurrent clinical trial that may impact the results of this study\n\n Intra-Operative Exclusion Criteria:\n21. Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) \\< 2 in any section\n22. Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A\n23. Any presenting condition discovered intraoperatively that in the opinion of the investigator would make participating in this study not in the participant's/patient's best interest. For example, presence of a stricture or tight sigmoid that would make passing an overtube risky for the patient\n24. Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study"}, 'identificationModule': {'nctId': 'NCT06935734', 'acronym': 'CARE I', 'briefTitle': 'Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neptune Medical'}, 'officialTitle': 'Colonoscopy With a Robotic Endoscope, The CARE I Study', 'orgStudyIdInfo': {'id': 'CP-000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': 'This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where the first phase (A) will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and the second phase (B) will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.', 'interventionNames': ['Diagnostic Test: Diagnostic Colonoscopy']}], 'interventions': [{'name': 'Diagnostic Colonoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aishwarya Gosai', 'role': 'CONTACT', 'email': 'aishwarya@neptunemedical.com', 'phone': '(949) 394 8073'}], 'overallOfficials': [{'name': 'Marcin Romanczyk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H-T Centrum Medyczne'}, {'name': 'Jason Samarasena, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}, {'name': 'Tomasz Romanczyk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H-T Centrum Medyczne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neptune Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KCRI', 'class': 'OTHER'}, {'name': 'H-T. Centrum Medyczne Sp. z o.o. sp. k', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}