Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02777203
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2016-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mjohnston@drcharlesmiller.com', 'phone': '6303641112', 'title': 'Mary Johnston', 'organization': 'The Advanced Gyn Surgery Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Patient were followed continuously for six weeks post-operatively.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Utilizing ecosacT400 Bag', 'description': 'Patients undergoing hysterectomy and myomectomy utilizing morcellation and the EcosacT400 bag', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 25, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'post op urinary retention', 'notes': 'post operative urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'umbillical drainage', 'notes': 'Incisional drainage post operative ( from surgical site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional pain', 'notes': 'post operative incisional pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'notes': 'Post operative chest pain due to Co2 gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'notes': 'Post operative diarrhea related to antibiotic use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'notes': 'post operative back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': 'Post operative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leg numbness', 'notes': 'Post operative numbness in thigh due to lithotomy positioning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken instrument', 'notes': 'A surgical instrument used during surgery broke apart inside patient .Surgery was stopped and all pieces were removed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bruising around incision sites', 'notes': 'Bruising noted around incisions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'post operative nausea', 'notes': 'nausea after surgery lasting greater than 24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Fatigue after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'notes': 'Post operative rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritoneal rent', 'notes': 'Espiner bag was introduced through umbilical port while not under direct vision and a rent was made in the peritoneum. the area was explored and no issues noted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'notes': 'post operative constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal discharge/yeast infection', 'notes': 'vaginal discharge/yeast infection post operative associated with antibiotic use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Egg Albumin Leakage.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Utilizing EcosacT400 Bag', 'description': 'Patients undergoing hysterectomy and myomectomy utilizing morcellation and new EcosacT400 bag'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 through the end of morcellation, approximately 30 minutes.', 'description': 'After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Morcellation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Utilizing EcosacT400 Bag', 'description': 'Patients undergoing hysterectomy and myomectomy utilizing morcellation and EcosacT400 bag'}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '14.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 through the end of morcellation, approximately 30 minutes.', 'description': 'Time (in minutes) from insertion of the bag to removal of the bag', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Undergoing Myomectomy or Hysterectomy With Morcellation', 'description': 'Subjects undergoing power morcellation with the EcoSac 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Only One Arm Was Utilized', 'description': 'one arm'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'women who underwent laparoscopic surgery utilizing morcellation in a bag'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-11', 'size': 220092, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-06T11:10', 'hasProtocol': True}, {'date': '2017-07-05', 'size': 213327, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-06T11:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2016-05-10', 'resultsFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-01', 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Egg Albumin Leakage.', 'timeFrame': 'Day 0 through the end of morcellation, approximately 30 minutes.', 'description': 'After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."'}], 'secondaryOutcomes': [{'measure': 'Morcellation Time', 'timeFrame': 'Day 0 through the end of morcellation, approximately 30 minutes.', 'description': 'Time (in minutes) from insertion of the bag to removal of the bag'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['morcellation', 'myomectomy', 'hysterectomy'], 'conditions': ['Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '25460317', 'type': 'BACKGROUND', 'citation': 'Cholkeri-Singh A, Miller CE. Power morcellation in a specimen bag. J Minim Invasive Gynecol. 2015 Feb;22(2):160. doi: 10.1016/j.jmig.2014.10.012. Epub 2014 Oct 18.'}, {'pmid': '25162248', 'type': 'BACKGROUND', 'citation': 'Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.'}, {'pmid': '24769447', 'type': 'BACKGROUND', 'citation': 'Einarsson JI, Cohen SL, Fuchs N, Wang KC. In-bag morcellation. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):951-3. doi: 10.1016/j.jmig.2014.04.010. Epub 2014 Apr 25.'}, {'pmid': '25198260', 'type': 'BACKGROUND', 'citation': 'Kho KA, Anderson TL, Nezhat CH. Intracorporeal electromechanical tissue morcellation: a critical review and recommendations for clinical practice. Obstet Gynecol. 2014 Oct;124(4):787-793. doi: 10.1097/AOG.0000000000000448.'}, {'pmid': '25452122', 'type': 'BACKGROUND', 'citation': 'Vargas MV, Cohen SL, Fuchs-Weizman N, Wang KC, Manoucheri E, Vitonis AF, Einarsson JI. Open power morcellation versus contained power morcellation within an insufflated isolation bag: comparison of perioperative outcomes. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):433-8. doi: 10.1016/j.jmig.2014.11.010. Epub 2014 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation.\n\nThe hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.', 'detailedDescription': 'Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.\n\nIn order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. Due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag.\n\nThis study will be evaluating the efficacy of contained morcellation using a specific specimen bag. Morcellation will be performed in the designated bag. The bag will then be removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult premenopausal women (equal or greater than 18 years old)\n* no symptoms of menopause\n* undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids\n* not candidates for specimen removal via mini-laparotomy incision (as deemed by the study surgeon) or who have refused mini-laparotomy\n* endometrial biopsy with no suspicion for malignancy\n\nExclusion Criteria:\n\n* known or suspected malignancy\n* peri- or post-menopausal women\n* specimen that can be removed without power morcellation (e.g., vaginally or through laparoscopic trocars)\n* adults unable to consent.'}, 'identificationModule': {'nctId': 'NCT02777203', 'briefTitle': 'Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy', 'orgStudyIdInfo': {'id': 'AHCIRB 6310 Power Morcellation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EcoSac 46 400 ECO-T morcellation bag cohort', 'description': 'Prospective study of one cohort of subjects undergoing power morcellation within the EcoSac 46 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.', 'interventionNames': ['Device: EcoSac 400 ECO-T']}], 'interventions': [{'name': 'EcoSac 400 ECO-T', 'type': 'DEVICE', 'description': 'Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag. This study is a pilot study with one arm (all patients will use the new EcoSac400 ECO-T bag.', 'armGroupLabels': ['EcoSac 46 400 ECO-T morcellation bag cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Lutheran General Hospital', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}], 'overallOfficials': [{'name': 'Charles Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Espiner Medical LTD', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}