Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT06501092
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Utility of the Point Mini in a Clinical Take-home Study
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ABILHAND-Kids', 'timeFrame': 'Baseline (pre-fitting)', 'description': "The ABILHAND-Kids is a measure of manual ability for children with upper limb impairment. ABILHAND-Kids consists of a questionnaire listing 21 manual activities and the child's parents respond with their perception of the child's performance and effort on a 3-point scale."}, {'measure': 'DISABKIDS', 'timeFrame': 'Baseline (pre-fitting)', 'description': 'The DISABKIDS questionnaire measures general quality of life and the level of distress caused by the chronic condition. Both self-report and parent proxy-report versions are available. It is suitable for pediatric patients between 4-16 years of age with chronic health conditions.'}, {'measure': 'ABILHAND-Kids', 'timeFrame': 'Immediately post-fitting', 'description': "The ABILHAND-Kids is a measure of manual ability for children with upper limb impairment. ABILHAND-Kids consists of a questionnaire listing 21 manual activities and the child's parents respond with their perception of the child's performance and effort on a 3-point scale."}, {'measure': 'DISABKIDS', 'timeFrame': 'Immediately post-fitting', 'description': 'The DISABKIDS questionnaire measures general quality of life and the level of distress caused by the chronic condition. Both self-report and parent proxy-report versions are available. It is suitable for pediatric patients between 4-16 years of age with chronic health conditions.'}, {'measure': 'ABILHAND-Kids', 'timeFrame': '30 days post-fitting', 'description': "The ABILHAND-Kids is a measure of manual ability for children with upper limb impairment. ABILHAND-Kids consists of a questionnaire listing 21 manual activities and the child's parents respond with their perception of the child's performance and effort on a 3-point scale."}, {'measure': 'DISABKIDS', 'timeFrame': '30 days post-fitting', 'description': 'The DISABKIDS questionnaire measures general quality of life and the level of distress caused by the chronic condition. Both self-report and parent proxy-report versions are available. It is suitable for pediatric patients between 4-16 years of age with chronic health conditions.'}, {'measure': 'ABILHAND-Kids', 'timeFrame': '60 days post-fitting', 'description': "The ABILHAND-Kids is a measure of manual ability for children with upper limb impairment. ABILHAND-Kids consists of a questionnaire listing 21 manual activities and the child's parents respond with their perception of the child's performance and effort on a 3-point scale."}, {'measure': 'DISABKIDS', 'timeFrame': '60 days post-fitting', 'description': 'The DISABKIDS questionnaire measures general quality of life and the level of distress caused by the chronic condition. Both self-report and parent proxy-report versions are available. It is suitable for pediatric patients between 4-16 years of age with chronic health conditions.'}], 'secondaryOutcomes': [{'measure': 'Weekly Diary Entries', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Throughout the study, subjects and their parents will fill out weekly logs asking their experiences during the day, number of hours wearing the device, descriptions of the tasks performed, and open-response sections to clarify/detail any other events. The weekly logs will be in sealed envelopes and not opened until the completion of the study by the experimenters.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amputation; Traumatic, Hand', 'Amputation, Congenital']}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time."}, '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 finger loss at the metacarpophalangeal (MCP) level\n* Intact thumb with full range of motion\n* Fluent in English\n* Age between 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': 'NCT06501092', 'briefTitle': 'To Assess the Utility of the Point Mini in a Clinical Take-home Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Point Designs'}, 'officialTitle': 'To Assess the Utility of the Point Mini in a Clinical Take-home Study', 'orgStudyIdInfo': {'id': '445970'}, 'secondaryIdInfos': [{'id': '4R44HD113485-02', 'link': 'https://reporter.nih.gov/quickSearch/4R44HD113485-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Current/No Device', 'description': "Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device."}, {'type': 'EXPERIMENTAL', 'label': 'Point Mini', 'description': 'Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \\~30 days post-fitting, and \\~60 days post-fitting.', 'interventionNames': ['Device: Point Mini']}], 'interventions': [{'name': 'Point Mini', 'type': 'DEVICE', 'description': 'Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets', 'armGroupLabels': ['Point Mini']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Connolly', 'role': 'CONTACT', 'email': 'becca@pointdesigns.com', 'phone': '720-600-4753'}, {'name': 'Levin Sliker, PhD', 'role': 'CONTACT', 'email': 'levin@pointdesigns.com', 'phone': '720-600-4753'}], 'facility': 'Point Designs', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '30143', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Coulter', 'role': 'CONTACT', 'email': 'Colleen.Coulter@choa.org', 'phone': '404-785-5684'}, {'name': 'Rebecca Connolly', 'role': 'CONTACT', 'email': 'becca@pointdesigns.com', 'phone': '720-600-4753'}], 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Rebecca Connolly', 'role': 'CONTACT', 'email': 'becca@pointdesigns.com', 'phone': '720-600-4753'}, {'name': 'Levin Sliker, PhD', 'role': 'CONTACT', 'email': 'levin@pointdesigns.com', 'phone': '720-600-4753'}], 'overallOfficials': [{'name': 'Levin Sliker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Point Designs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Point Designs', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}