Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT07031050
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary safety outcome', 'timeFrame': 'up to 42 days after surgery', 'description': 'Occurrence of Clavien-Dindo grades III-V adverse events'}, {'measure': 'Primary efficacy outcome', 'timeFrame': 'Intraoperative', 'description': 'Successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sacrocolpopexy']}, 'descriptionModule': {'briefSummary': 'This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing a sacrocolpopexy or sacrocervicopexy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged \\> 18 years\n* Women with symptomatic stage I or greater pelvic organ prolapse (POP-Q)\n* Patient agrees to perform the 6-week follow-up assessment as per Standard of Care\n\nExclusion Criteria:\n\n* Any planned non-urogynaecological concomitant procedures\n* History of previous POP surgery, with the exception of transvaginal approaches without mesh implantation\n* Previous surgery and/or radiation for urologic, gastrointestinal or gynecologic cancer\n* History of Crohn's disease\n* Chronic colitis"}, 'identificationModule': {'nctId': 'NCT07031050', 'acronym': 'SPARO', 'briefTitle': 'Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Distalmotion SA'}, 'officialTitle': 'Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance', 'orgStudyIdInfo': {'id': '2024-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sacrocolpopexy or sacrocervicopexy', 'type': 'DEVICE', 'description': 'Robotic-assisted sacrocolpopexy or sacrocervicopexy with the Dexter robotic surgery system'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Neymeyer, MD', 'role': 'CONTACT', 'email': 'joerg.neymeyer@charite.de', 'phone': '+4930450515272'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dominique Könsgen-Mustea, MD', 'role': 'CONTACT', 'email': 'gynaekologie@ukbonn.de', 'phone': '+4922828715444'}], 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Damme', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Holthaus, MD', 'role': 'CONTACT', 'email': 'ambulanz.holthaus@krankenhaus-damme.de', 'phone': '+41549160360'}], 'facility': 'Krankenhaus St. Elisabeth', 'geoPoint': {'lat': 52.52157, 'lon': 8.19793}}, {'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fabinshy Thangarajah, MD', 'role': 'CONTACT', 'email': 'fabinshy.thangarajah@uk-essen.de', 'phone': '+492017233570'}], 'facility': 'Universitätsmedizin Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Michael Müller, MD', 'role': 'CONTACT', 'email': 'chefarztsekretariat.gynaekologie@insel.ch', 'phone': '+41316321203'}], 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Interlaken', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Matthias Streich, MD', 'role': 'CONTACT', 'email': 'matthias.streich@spitalfmi.ch', 'phone': '+41338262626'}], 'facility': 'Spitäler FMI AG', 'geoPoint': {'lat': 46.68387, 'lon': 7.86638}}], 'centralContacts': [{'name': 'Pascal Lehmann', 'role': 'CONTACT', 'email': 'pascal.lehmann@distalmotion.com', 'phone': '+41215105890'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Distalmotion SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Confinis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}