Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-18 @ 3:34 PM
Study NCT ID:
NCT06504667
Status:
WITHDRAWN
Last Update Posted:
2025-12-17
First Post:
2024-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Validate Point Mini User Needs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565682', 'term': 'Amputation, Congenital'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Early termination of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAL-1', 'timeFrame': 'Day 1 (8 hours)', 'description': 'User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)'}, {'measure': 'VAL-2', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)'}, {'measure': 'VAL-3.1', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)'}, {'measure': 'VAL-3.2', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)'}, {'measure': 'VAL-4', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)'}, {'measure': 'VAL-5', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)'}, {'measure': 'VAL-6', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)'}, {'measure': 'VAL-7', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)'}, {'measure': 'VAL-8', 'timeFrame': 'Day 1 (10 minutes)', 'description': 'User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)'}, {'measure': 'VAL-9', 'timeFrame': 'Day 1 (8 hours)', 'description': 'User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amputation; Traumatic, Hand', 'Amputation, Congenital']}, 'descriptionModule': {'briefSummary': 'The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partial hand loss with at least index and/or middle fingers loss at the MCP level\n* Intact thumb with full range of motion\n* Fluent in English\n* Between the ages of 5 and 15 years\n\nExclusion Criteria:\n\n* Patients with a residual limb that is unhealed from the amputation surgery\n* Unhealed wounds\n* Significant cognitive deficits as determined upon clinical evaluation\n* Significant neurological deficits as determined upon clinical evaluation\n* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation\n* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation\n* Serious uncontrolled medical problems as judged by the project therapist'}, 'identificationModule': {'nctId': 'NCT06504667', 'briefTitle': 'To Validate Point Mini User Needs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Point Designs'}, 'officialTitle': 'To Validate Point Mini User Needs', 'orgStudyIdInfo': {'id': '445969'}, 'secondaryIdInfos': [{'id': '4R44HD113485-02', 'link': 'https://reporter.nih.gov/quickSearch/4R44HD113485-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prosthesis', 'description': 'Patient is temporarily fit with Point Mini finger prosthetic system', 'interventionNames': ['Device: Point Mini']}], 'interventions': [{'name': 'Point Mini', 'type': 'DEVICE', 'description': 'The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets', 'armGroupLabels': ['Prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver | Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'country': 'United States', 'facility': 'Point Designs', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}], 'overallOfficials': [{'name': 'Levin Sliker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEO, Point Designs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Point Designs', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}