Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-27 @ 12:11 AM
Study NCT ID:
NCT00891657
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D009214', 'term': 'Myoma'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'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'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '609-275-0500', 'title': 'Director, Medical Affairs', 'organization': 'Integra LifeSciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.'}}, 'adverseEventsModule': {'timeFrame': '10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date)', 'eventGroups': [{'id': 'EG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Sites Adherent to the Uterus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-12 weeks post myomectomy', 'description': 'The number of times an adhesion is attached to the uterus.', 'unitOfMeasure': 'Adhesion Sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects to have had a second laparoscopic look.'}, {'type': 'PRIMARY', 'title': 'Mean Severity Score of Sites Adherent to the Uterus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-12 weeks post myomectomy', 'description': 'The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects to have had a second laparoscopic look.'}, {'type': 'PRIMARY', 'title': 'Mean Extent Score of Sites Adherent to the Uterus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-12 weeks post myomectomy', 'description': "0 =no adhesions, 1=covering \\<25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering \\>51% of locations' total area.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area of Sites Adherent to the Uterus (cm^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-12 weeks post myomectomy', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between November 10, 2008 and March 4, 2009, a total of 15 subjects were consented for potential participation, of whom all 15 subjects were randomized. There were no intra-operative screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SprayShield™', 'description': 'The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.'}, {'id': 'BG001', 'title': 'Control', 'description': 'The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2009-04-30', 'resultsFirstSubmitDate': '2010-07-13', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-08-10', 'studyFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Sites Adherent to the Uterus', 'timeFrame': '8-12 weeks post myomectomy', 'description': 'The number of times an adhesion is attached to the uterus.'}, {'measure': 'Mean Severity Score of Sites Adherent to the Uterus', 'timeFrame': '8-12 weeks post myomectomy', 'description': 'The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.'}, {'measure': 'Mean Extent Score of Sites Adherent to the Uterus', 'timeFrame': '8-12 weeks post myomectomy', 'description': "0 =no adhesions, 1=covering \\<25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering \\>51% of locations' total area."}, {'measure': 'Area of Sites Adherent to the Uterus (cm^2)', 'timeFrame': '8-12 weeks post myomectomy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adhesion', 'Fibroid', 'Myoma', 'Leiomyoma', 'Myomectomy'], 'conditions': ['Fibroid', 'Myoma', 'Leiomyoma']}, 'descriptionModule': {'briefSummary': 'This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females, 18 years of age or older, of child-bearing potential.\n* Subject has at least one myoma \\>= 3 cm.\n\nExclusion Criteria:\n\n* Pregnant or lactating females.\n* Females undergoing prior open or closed myomectomy for treatment of myomas.\n* Evidence of current active endometriosis or infection\n* History of or active inflammatory bowel disease or pelvic inflammatory disease.\n* Presence of a frozen pelvis, or hydrosalpinges.'}, 'identificationModule': {'nctId': 'NCT00891657', 'briefTitle': 'Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy', 'orgStudyIdInfo': {'id': 'GYN-08-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SprayShield™', 'description': 'SprayShield™', 'interventionNames': ['Device: SprayShield™']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No adhesion barrier administered.'}], 'interventions': [{'name': 'SprayShield™', 'type': 'DEVICE', 'description': 'Anti-adhesion barrier', 'armGroupLabels': ['SprayShield™']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Pius Clinic', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}], 'overallOfficials': [{'name': 'Rudy Leon De Wilde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pius Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}