User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use

Launched by QART MEDICAL · Jan 30, 2024

Nctid: NCT06232720

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"The study will be an open label study, non-controlled and non-randomized."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2023-07-03", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Usability", "timeFrame"=>"1 year", "description"=>"Usability surveys to users including user manual comprehensiveness questionnaire (evaluation of critical steps in the procedure, correct use, feedback on training provided)."}, {"measure"=>"Usable blastocyst formation rate", "timeFrame"=>"5 days", "description"=>"Number of usable (transferred or frozen) embryos per cycle (Gardner 2BB at day 5 or equivalent or grade \"good\" according to Istanbul consensus for cleavage-stage."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["to Aid in Sperm Selection for ICSI"]}, "descriptionModule"=>{"briefSummary"=>"User Site Testing Study to evaluate usability of the Q300™ device under \"real-life conditions\" in a reproductive laboratory environment use.", "detailedDescription"=>"Testing the Usability of the Q300™ device.\n\nSpecific objectives of this evaluation are as follows:\n\n* Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application.\n* Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device.\n* Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use.\n* Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells.\n* Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations.\n* Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells.\n* Evaluate effect of using the Q300 on the clinical outcome"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient intended for ICSI recruited from the hospital's IVF (both male and female are considered patients in this study).\n* Male, Age \\>18 yrs\n* Female age \\< 40 yrs\n* Patients signed informed consent prior study procedures.\n* Fresh Oocytes\n* Fresh ejaculated motile sperm and presence of motile sperm at the time of sperm selection for ICSI\n* Fresh oocytes\n* Non severe male factor (TMC\\>1\\*10\\^6/mL)\n* Unexplained factor infertility\n* AFC \\>=13mm during ovarian stimulation prior to ovulation trigger or induction#\\>=5 in the cycle\n\nExclusion Criteria:\n\n* Frozen spermatozoa\n* Immotile sperm\n* Severe Oligozoospermia (less than 1 million sperm cells after preparation).\n* Spermatozoa extracted by TESA/ TESE\n* Frozen oocytes\n* Egg or ovulatory female factor such as low ovarian reserve (menstrual cycle, per AFC. AMH test- if performed) or non-typical eggs or eggs with severe pathology (qualitative; please find\n* That the instructions for use of Q300TM have not been fully followed (poor quality of images etc...)\n* Inability to reliably trace sperm-oocyte-embryo clinical outcome throughout the process."}, "identificationModule"=>{"nctId"=>"NCT06232720", "briefTitle"=>"User Site Testing Study to Evaluate Usability of the Q300™ Device Under \"Real-life Conditions\" in a Reproductive Laboratory Environment Use", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"QART Medical"}, "officialTitle"=>"Q300 User Site Testing Study", "orgStudyIdInfo"=>{"id"=>"Q300-02"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Q300 QART Medical", "type"=>"DEVICE", "description"=>"The Q300TM Imaging system includes a Quantitative Phase Microscope. Q300TM uses a low intensity coherent light source, in a uniquely configured interferometer, which measures light delay as it passes different locations across the sperm cell. The amount"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Ashkelon", "status"=>"RECRUITING", "country"=>"Israel", "contacts"=>[{"name"=>"Yulia Michaelov, Dr.", "role"=>"CONTACT"}], "facility"=>"Barzilay Medical Center", "geoPoint"=>{"lat"=>31.66926, "lon"=>34.57149}}], "centralContacts"=>[{"name"=>"Orly Schwartz", "role"=>"CONTACT", "email"=>"orlyschwartz@qart-medical.com", "phone"=>"0545936673"}], "overallOfficials"=>[{"name"=>"Orly Schwartz", "role"=>"STUDY_DIRECTOR", "affiliation"=>"QART Medical"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"QART Medical", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}