Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT04455035
Status:
TERMINATED
Last Update Posted:
2024-12-30
First Post:
2020-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Brett.T.Chiquet@uth.tmc.edu', 'phone': '7135008220', 'title': 'Brett Chiquet, DDS, PhD, Associate Professor', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'description': 'Parents of patients in "treatment"/prospective arm could report challenges/pitfalls to investigator team, and investigator team met with family monthly (4 months, 20-30 minute appointments) to collect data and evaluate. Adverse event data were not collected for the retrospective arm, as IRB approval was not requested to contact retrospective participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'OG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.601', 'spread': '0.236', 'groupId': 'OG000'}, {'value': '0.435', 'spread': '0.111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0088', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'ttest'}], 'paramType': 'MEAN', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.', 'unitOfMeasure': 'pixels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'OG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.93', 'spread': '5.124', 'groupId': 'OG000'}, {'value': '64.75', 'spread': '4.991', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'ttest'}], 'paramType': 'MEAN', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'OG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}], 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'OG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}], 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'OG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}], 'classes': [{'title': 'improvement in quality of life', 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'no change in quality of life', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'decrease in quality of life', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'The Infant and New Parent Quality of Life questionnaire consists of 22 questions related to quality of life. For each question, it was determined whether the response at 3 months indicated an improvement, no change, or a decrease in quality of life relative to the response at the time of initial examination. The average number with an improvement in quality of life (averaged over all 22 questions), the average number who had no change in quality of life (averaged over all 22 questions), and the average number who had a decrease in quality of life (averaged over all 22 questions) are reported.', 'unitOfMeasure': 'number of responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from the retrospective arm, as IRB approval was not requested to contact retrospective participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'FG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Retrospective Group(Control)', 'description': 'Comparator: Retrospective Group(Control): The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.'}, {'id': 'BG001', 'title': 'Prospective Group', 'description': 'Prospective Group: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data for this measure were not collected.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-16', 'size': 1031326, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-28T09:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'PI left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2020-06-26', 'resultsFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-05', 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.'}, {'measure': 'Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.'}, {'measure': 'Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.'}, {'measure': 'Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.'}], 'secondaryOutcomes': [{'measure': 'Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire', 'timeFrame': 'initial time of examination with study team, time of surgery (3 months post intervention)', 'description': 'The Infant and New Parent Quality of Life questionnaire consists of 22 questions related to quality of life. For each question, it was determined whether the response at 3 months indicated an improvement, no change, or a decrease in quality of life relative to the response at the time of initial examination. The average number with an improvement in quality of life (averaged over all 22 questions), the average number who had no change in quality of life (averaged over all 22 questions), and the average number who had a decrease in quality of life (averaged over all 22 questions) are reported.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dynacleft'], 'conditions': ['Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRetrospective Group:\n\n* Unilateral cleft lip with or without cleft palate\n* Patients of a single surgeon (Matthew Greives, MD)\n* Patients with complete photographs:\n\n * After birth, first visit\n * At cleft lip repair (3-4 months)\n * Post-operative cleft repair (about 1 year of age)\n\nProspective Group:\n\n* Patients with incomplete unilateral cleft lip with or without cleft palate\n* Patients of any surgeon\n\nExclusion Criteria:\n\nRetrospective Group:\n\n* Bilateral cleft lip or complete unilateral cleft lip\n* Patients operated on by other primary surgeons\n* Patients with incomplete photo records will be evaluated to determine if the patient should be excluded\n\nProspective Group:\n\n* Patients with bilateral cleft lip or complete unilateral cleft lip\n* Patients whose parents refuse to consent to inclusion\n* Patients with tape allergies to the adhesive of the DynaCleft®\n* Patients with syndromic craniofacial conditions or Tessier type facial clefts'}, 'identificationModule': {'nctId': 'NCT04455035', 'briefTitle': 'DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants', 'orgStudyIdInfo': {'id': 'HSC-DB-20-0311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Retrospective Group(Control)', 'interventionNames': ['Other: Comparator: Retrospective Group(Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Prospective Group', 'interventionNames': ['Device: Prospective Group']}], 'interventions': [{'name': 'Comparator: Retrospective Group(Control)', 'type': 'OTHER', 'description': 'The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.', 'armGroupLabels': ['Retrospective Group(Control)']}, {'name': 'Prospective Group', 'type': 'DEVICE', 'description': 'The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.\n\nDynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.\n\nLinear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.', 'armGroupLabels': ['Prospective Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Brett T Chiquet, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brett Thomas Chiquet', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}