Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06442358
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2024-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being', 'timeFrame': 'One day', 'description': 'Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level'}], 'secondaryOutcomes': [{'measure': 'Assess preliminary effectiveness and compare participant results to standard of care BPP', 'timeFrame': 'One day', 'description': 'The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP'}, {'measure': 'Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.', 'timeFrame': 'One day', 'description': 'Patients will answer a questionnaire about their experience using Pulsenmore device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Perinatal Care']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Singleton pregnancy\n* Gestational age ≥ 24 0/7 weeks\n* No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)\n* Ability to understand and sign informed consent in English\n* Ability to read and understand instructions in English\n* Ability to hold an ultrasound probe and respond to clinician instructions\n* BMI less than 40 at initial prenatal visit\n* Scheduled biophysical profile (BPP)\n* Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.\n\nExclusion Criteria:\n\n* Multiple gestation\n* Known major fetal structural anomaly or aneuploidy\n* Known fetal or genetic anomalies\n* Ruptured membranes\n* Uterine complaints, such as painful contractions\n* Maternal concern for decreased fetal movement\n* Not evaluated vaginal bleeding (not including spotting)\n* Fetal or maternal criteria that require urgent delivery\n* BMI ≥ 40 at initial prenatal visit'}, 'identificationModule': {'nctId': 'NCT06442358', 'briefTitle': 'Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept', 'organization': {'class': 'INDUSTRY', 'fullName': 'PulseNmore'}, 'officialTitle': 'BPP for ME: Self Biophysical Profile Proof of Concept', 'orgStudyIdInfo': {'id': 'HUM00244136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm home ultrasound in pregnant women require BPP', 'description': 'Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician', 'interventionNames': ['Device: Pulsenmore ES home ultrasound device']}], 'interventions': [{'name': 'Pulsenmore ES home ultrasound device', 'type': 'DEVICE', 'description': 'Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider', 'armGroupLabels': ['Single Arm home ultrasound in pregnant women require BPP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Alex Peahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PulseNmore', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}