Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-19 @ 7:29 PM
Study NCT ID:
NCT04573959
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2020-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to capture images', 'timeFrame': '2 weeks', 'description': 'Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.'}, {'measure': 'Ability to download images', 'timeFrame': '2 weeks', 'description': 'Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3).'}, {'measure': 'Diagnostic Quality of Images', 'timeFrame': '2 weeks', 'description': 'Small bowel images of diagnostic quality are able to be reviewed using the CapsoView CVV Software and determined to be effective for diagnostic purposes by the study investigator.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intestinal Disease', 'Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcer', 'Celiac Disease', 'Angioectasia', 'Polyp'], 'conditions': ['Intestinal Disease', 'Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcer', 'Celiac Disease']}, 'descriptionModule': {'briefSummary': 'To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.', 'detailedDescription': 'The purpose of the study is validate the an updated version of the CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.\n\nThe system to be validated consists of an updated version of the CapsoCam® SV-3 video capsule endoscope, the CapsoView® CVV Software, the CapsoAccess ® Capsule Data Access System (CDAS3) and the CapsoRetrieve® Capsule Retrieval Kit for the collection of the excreted CapsoCam capsule.\n\nThe captured CapsoCam® SV-3 capsule images of the small bowel will be downloaded via the CapsoAccess® Capsule Data Access System (CDAS3) to a computer and proprietary CapsoView® CVV Software is used to review capsule images. The CapsoView® software displays the video and employs a variety of image-enhancement, video playback, and image analysis features to facilitate physician review of the captured images. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report, which aids in diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Willing and able to provide written informed consent\n* Completion of pre-study questionnaire\n* Approval of study principal investigator\n\nExclusion Criteria:\n\n* Subjects with abdominal pain of unknown origin\n* Difficulty Swallowing\n* Known or suspected gastrointestinal disease\n* Diarrhea or constipation\n* Anemia of unknown origin\n* Rectal or other gastrointestinal bleeding\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04573959', 'briefTitle': 'Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Capso Vision, Inc.'}, 'officialTitle': 'Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System', 'orgStudyIdInfo': {'id': 'CVI-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SV-3 Capsule Endoscopy', 'description': 'CapsoCam SV-3 Capsule Endoscopy system will perform in a manner consistent with the performance of the CapsoCam SV-3 capsule endoscopy systems.', 'interventionNames': ['Device: SV-3 Capsule Endoscopy']}], 'interventions': [{'name': 'SV-3 Capsule Endoscopy', 'type': 'DEVICE', 'otherNames': ['Capsule Endoscopy System'], 'description': 'The purpose of this study is to validate an updated version of the CapsoCam SV-3 Endoscopy System with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam SV-3 capsule endoscopy.', 'armGroupLabels': ['SV-3 Capsule Endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95070', 'city': 'Saratoga', 'state': 'California', 'country': 'United States', 'facility': 'CapsoVision, Inc.', 'geoPoint': {'lat': 37.26383, 'lon': -122.02301}}], 'overallOfficials': [{'name': 'David Shields, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CapsoVision Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capso Vision, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Generic Devices Consulting, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}