Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-08 @ 3:51 PM
Study NCT ID:
NCT02991794
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2016-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostatectomies Using Einstein Vision® 3D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]', 'timeFrame': 'Intraoperatively', 'description': 'learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system'}], 'secondaryOutcomes': [{'measure': 'Intraoperative blood loss [ml]', 'timeFrame': 'Intraoperatively'}, {'measure': 'Intraoperative blood transfusions [quantity]', 'timeFrame': 'Intraoperatively'}, {'measure': 'Postoperative blood transfusions [quantity]', 'timeFrame': 'Postoperatively'}, {'measure': 'Intraoperative incidence of complications [percentage]', 'timeFrame': 'Intraoperatively', 'description': '(e.g. bleedings, Trauma of ureter)'}, {'measure': 'Postoperative incidence of complications [percentage]', 'timeFrame': 'During stay in Hospital (5-12 days postoperatively)', 'description': '(e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)'}, {'measure': "Surgeon's experience with different operation methods and application systems", 'timeFrame': 'After first intervention for each hospital and after study completion, an average of 1 year later', 'description': 'using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In)'}, {'measure': "Patient's quality of life", 'timeFrame': 'Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively', 'description': "Pre- and postoperative patient's quality of life using the questionnaire EQ-5D-5L\n\nThe following dimensions are assessed:\n\n* Mobility\n* Self-care\n* Usual activities\n* Pain / discomfort\n* Anxiety / depression\n* Health"}, {'measure': 'Operation time [min.]', 'timeFrame': 'Intraoperatively'}, {'measure': 'Intraoperative usability of the device', 'timeFrame': 'Intraoperatively', 'description': 'using a questionnaire containing different dimensions and a 5-point assessment level (Likert Scale: 1 = excellent, 5 = unacceptable).\n\nThe following dimensions are assessed:\n\n* Control\n* Expenditure of energy\n* Image quality\n* Overall satisfaction'}, {'measure': 'Incontinence after catheterization [percentage]', 'timeFrame': 'During stay in Hospital (5-12 days postoperatively)'}, {'measure': 'Postoperative hospital stay [days]', 'timeFrame': 'During stay in Hospital (5-12 days postoperatively)'}, {'measure': 'Return to erectile function [percentage]', 'timeFrame': '12 months'}, {'measure': 'Return to continence function [percentage]', 'timeFrame': '12 months'}, {'measure': 'Incontinence pads/pants per day [quantity]', 'timeFrame': '5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively'}, {'measure': 'Postoperative patient satisfaction', 'timeFrame': '5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively', 'description': 'using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostatectomy', 'laparoscopy', '3D visualization', 'learning curve', 'anastomosis'], 'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is collecting clinical data on the learning curve of different surgeons using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision®\n* Written informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Previous TURP (= transurethral resection of the prostate)\n* Previous operations on the sigmoid colon or rectum (e.g. because of carcinoma, perforation, diverticulum)\n* BMI \\> 35 kg/m²\n* Participation in another clinical study\n* Representation by a legal guardian or under involuntary commitment'}, 'identificationModule': {'nctId': 'NCT02991794', 'acronym': 'PROSTEVIS', 'briefTitle': 'Prostatectomies Using Einstein Vision® 3D', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System', 'orgStudyIdInfo': {'id': 'AAG-O-H-1607'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EinsteinVision 3D visualization system', 'type': 'DEVICE', 'description': 'Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63069', 'city': 'Offenbach', 'country': 'Germany', 'facility': 'Sana Klinikum Offenbach', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}, {'zip': '73760', 'city': 'Ostfildern', 'country': 'Germany', 'facility': 'medius Klinik Ostfildern-Ruit', 'geoPoint': {'lat': 48.72704, 'lon': 9.24954}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}