Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT06792851
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECHO-012 Kosmos Bladder Clinical Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manual Bladder Volume vs. Kosmos Automated Bladder Volume', 'timeFrame': 'Post data acquisition (one month)', 'description': 'Kosmos Automated Bladder Volume and exam images will be captured using the Kosmos Ultrasound Diagnostic System by a nurse and a sonographer for each participant with both a full and empty bladder. Three independent sonographers will manually measure exam images for bladder length (L), width (W), and height (H). Volume will be calculated using: Bladder Volume = k×L×D×W where k is the correction coefficient. These results from the three sonographers will be averaged. The Pearson correlation coefficient between the average manual bladder volume and the Kosmos calculated pre-void volume will be calculated using the following equation: r=\\[∑(x-xbar)(y-ybar)\\]/\\[∑(x-xbar)\\^2 ∑(y-ybar)\\^2\\] Where x is the manual bladder volume, y is the Kosmos bladder volume, xbar is the mean of the manual bladder volume, and ybar is the mean of the Kosmos bladder volume. A successful outcome would be a correlation coefficient (r) of \\>0.90 on bladder exams acquired by both nurses and sonographers.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bladder Disease', 'Bladder Retention Volume', 'Bladder Dysfunction', 'Bladder Function']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the Kosmos Automatic Bladder Volume to the manual annotated bladder volume in participants across gender (male and female), age (children ages 7-17 and adults 18-89), and BMI strata (low to normal and high BMI). The hypothesis it aims to evaluate is: The Pearson correlation coefficient between Kosmos estimated bladder volume and manually annotated bladder volume will yield more than 0.90.\n\nParticipants will:\n\n* Have their full bladders scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System by both a nurse and sonographer.\n* Participants will void and measure their urine volume.\n* Participants empty bladders will be scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System again by both a nurse and sonographer.\n* Three sonographers will manually annotate the pre- and post-void exam images for each patient to calculate the manually annotated bladder volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Read and sign an English consent form, or assent form, in the case of a minor child\n* Read and complete an English demographic and general health survey, or have an LAR complete it for them in the case of a minor child\n* Give consent for participation, or assent in the case of a minor child\n* Able and willing to comply with study requirements\n* Follow fluid consumption requirements prior to the study visit\n* Those aged 7 years through 89 years, healthy as well as individuals with pelvic region abnormalities (if applicable), including but not limited to:\n\n i) Bladder cancer ii) Thickened bladder wall iii) Bladder stones iv) Current bladder or urinary tract infection\n\nExclusion Criteria:\n\n* Adults over 89 years old\n* Children under the age of 7\n* Persons who are pregnant\n* Persons who report an empty bladder upon arrival at their scheduled study visit\n* Children in foster care, as a foster parent may not legally consent for a foster child\n* Those who cannot or refuse to sign their consent or assent (including those with an LAR willing to provide consent)\n* Those who cannot provide informed consent or whose LAR cannot provide consent\n* Those who cannot speak or read English\n* Participants from ECHO-010 Bladder AI Training and Validation Data Collection Study'}, 'identificationModule': {'nctId': 'NCT06792851', 'briefTitle': 'ECHO-012 Kosmos Bladder Clinical Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'EchoNous Inc.'}, 'officialTitle': 'ECHO-012 Kosmos Bladder Clinical Validation Study', 'orgStudyIdInfo': {'id': 'ECHO-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bladder Volume Measurement', 'description': 'Pre- and post-void bladder volume assessment using Kosmos device by both nurse and sonographer and void volume measurement.', 'interventionNames': ['Device: Kosmos Bladder Volume Algorithm']}], 'interventions': [{'name': 'Kosmos Bladder Volume Algorithm', 'type': 'DEVICE', 'description': 'Participants underwent Kosmos bladder volume assessment by both a nurse and an abdominal sonographer pre-void. Participants voided and measured void volume. Participants underwent Kosmos bladder volume assessment by both a nurse and an abdominal sonographer post-void. Kosmos calculated volume measurements were compared to volume measurements calculated using calipers placed by sonographers by hand.', 'armGroupLabels': ['Bladder Volume Measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Sheryl Marks, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rainier Clinical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EchoNous Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rainier Clinical Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}