Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT01026805
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john@interlacemedical.com', 'phone': '508-875-1343', 'title': 'John Vozella, V.P. Clinical & Regulatory Affairs', 'phoneExt': '112', 'organization': 'Interlace Medical, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Small number of cases; retrospective study design'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Treatment Time Per Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '22.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of treatment', 'description': 'mean morcellation(division into and removal of small pieces, as of tissue) time per patient', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluid Volume Per Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '5179.0', 'groupId': 'OG000', 'lowerLimit': '600', 'upperLimit': '24000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of treatment', 'description': 'mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.', 'unitOfMeasure': 'mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluid Deficit Per Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '567.8', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '1900'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of treatment', 'description': 'mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.', 'unitOfMeasure': 'mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resected Tissue Weight Per Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '45.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of treatment', 'description': 'mean weight of resected tissue per patient', 'unitOfMeasure': 'g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-3 months post treatment', 'description': 'a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator("1" = "poor" and "10" = "excellent").', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treating physicians completed a survey questionnaire.'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-3 months post-treatment', 'description': 'Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Tissue Removed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediately post-treatment', 'description': 'mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.', 'unitOfMeasure': 'Percentage of tissue removed', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'An unselected series of eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator at four hospital or ambulatory surgical center sites were assessed for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hysteroscopic Morcellator Treatment Group', 'description': 'Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'size of fibroid or polyp', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'BG000', 'lowerLimit': '5.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEAN', 'description': 'measure size of pathology pre-treament via ultrasound or hysteroscopic exam', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-20', 'studyFirstSubmitDate': '2009-04-30', 'resultsFirstSubmitDate': '2009-04-30', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-03', 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Tissue Removed', 'timeFrame': 'immediately post-treatment', 'description': 'mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.'}], 'secondaryOutcomes': [{'measure': 'Treatment Time Per Patient', 'timeFrame': 'at time of treatment', 'description': 'mean morcellation(division into and removal of small pieces, as of tissue) time per patient'}, {'measure': 'Fluid Volume Per Procedure', 'timeFrame': 'at time of treatment', 'description': 'mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.'}, {'measure': 'Fluid Deficit Per Procedure', 'timeFrame': 'at time of treatment', 'description': 'mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.'}, {'measure': 'Resected Tissue Weight Per Patient', 'timeFrame': 'at time of treatment', 'description': 'mean weight of resected tissue per patient'}, {'measure': 'Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score', 'timeFrame': '2-3 months post treatment', 'description': 'a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator("1" = "poor" and "10" = "excellent").'}, {'measure': 'Adverse Events', 'timeFrame': '2-3 months post-treatment', 'description': 'Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['morcellator', 'hysteroscope', 'myomectomy', 'polypectomy', 'uterine fibroids'], 'conditions': ['Abnormal Uterine Bleeding', 'Infertility']}, 'descriptionModule': {'briefSummary': 'This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.', 'detailedDescription': 'A retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. Four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type I (mostly within the cavity) and type II (\\< 40% within the cavity) submucous myomas. Percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. Each of the four treating physicians also evaluated device performance using a 10 point scale (1 = "poor" and 10 = "excellent").'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator to resect intrauterine pathology (polyps and submucous myomas).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* at least 18 years old\n* treated for intra-uterine submucosal fibroids (Type 0 or 1 myomas and/or polyps using the Interlace 1st generation morcellator device.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01026805', 'briefTitle': 'Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hologic, Inc.'}, 'officialTitle': 'Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator', 'orgStudyIdInfo': {'id': 'TMP 200901'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hysteroscopic Morcellator', 'description': '11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device.', 'interventionNames': ['Device: Interlace Medical 1st Generation Hysteroscopic Morcellator']}], 'interventions': [{'name': 'Interlace Medical 1st Generation Hysteroscopic Morcellator', 'type': 'DEVICE', 'otherNames': ['MyoSure Tissure Removal System', 'MyoSure Tissure Removal Device'], 'description': 'The Interlace Medical hysteroscopic morcellator system has been cleared by the FDA(K073690)and consists of a motor drive unit connected to a 3mm morcellator. The morcellator is approximately 12 cm long and is equipped with an open channel that houses a reciprocating blade. When the motor is activated, the reciprocating blade will cut the tissue within the channel. The tissue travels down the 3mm morcellator shaft cannula via suction coupled to the proximal end of the morcellator and is captured in a tissue trap in a suction canister for pathological diagnosis following the procedure.', 'armGroupLabels': ['Hysteroscopic Morcellator']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles Miller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hologic, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}