Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-04 @ 9:13 AM
Study NCT ID:
NCT06958250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Endoscopic Bite Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013272', 'term': 'Stomach Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of successful completion of upper endoscopy procedures with novel bite block', 'timeFrame': 'Day 1', 'description': 'Documented on procedure survey'}], 'secondaryOutcomes': [{'measure': 'Endoscopist satisfaction', 'timeFrame': 'Day 1', 'description': 'Documented on procedure survey'}, {'measure': 'Absence of dental injury during endoscopy', 'timeFrame': 'Day 1', 'description': 'Documented on procedure survey'}, {'measure': 'Decreased need for manual bite block securing during endoscopy', 'timeFrame': 'Day 1', 'description': 'Documented on procedure survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Disease']}, 'descriptionModule': {'briefSummary': 'This study will test a novel endoscopic bite block during upper endoscopy.', 'detailedDescription': 'This study will feasibility and comfort of the novel endoscopic bite block that contains a compressible addition to the traditional endoscopic bite block offering cushioning for the teeth and the ability to resist mispositioning when a patient opens their mouth (ie, during a yawn).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, \\> 18 years of age\n4. Deemed appropriate for scheduled upper endoscopy by endoscopy and anesthesia staff\n\nExclusion Criteria:\n\n1\\. Known allergic reactions to components of the novel endoscopic bite block'}, 'identificationModule': {'nctId': 'NCT06958250', 'briefTitle': 'Novel Endoscopic Bite Block', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Novel Endoscopic Bite Block', 'orgStudyIdInfo': {'id': '857779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Novel Bite Block', 'description': 'Patients will utilize the novel Bite Block during routine endoscopic procedure', 'interventionNames': ['Device: Novel Bite Block']}], 'interventions': [{'name': 'Novel Bite Block', 'type': 'DEVICE', 'description': 'Patients to utilize novel bite block during routine endoscopic procedures', 'armGroupLabels': ['Novel Bite Block']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}