Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-03 @ 3:28 AM
Study NCT ID:
NCT02338505
Status:
UNKNOWN
Last Update Posted:
2015-01-14
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative complication rate', 'timeFrame': 'intraoperative', 'description': 'Operative time, conversion rate, estimated blood loss, visceral injury'}], 'secondaryOutcomes': [{'measure': 'postoperative complication rate', 'timeFrame': '30 days', 'description': 'Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Robotic Surgery', 'Telelap-ALFX', 'Gynecological disease'], 'conditions': ['Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis']}, 'referencesModule': {'references': [{'pmid': '23225591', 'type': 'RESULT', 'citation': 'Gidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5.'}, {'pmid': '24706079', 'type': 'RESULT', 'citation': 'Gidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40.'}, {'pmid': '25225214', 'type': 'RESULT', 'citation': 'Lococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15.'}, {'pmid': '25433265', 'type': 'RESULT', 'citation': 'Falavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41.'}], 'seeAlsoLinks': [{'url': 'https://www.policlinicogemelli.it', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Phase II prospective single-institutional study.', 'detailedDescription': 'The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* 30 ≤ BMI \\< 40\n* ASA \\< III\n* Ovarian Cyst\n* Prophylactic bilateral salpingo-oophorectomy\n* Ectopic Pregnancy\n* Pelvic Inflammatory Disease\n* Sterility/Infertility\n* Benign uterine disease (fibromatosis, adenomyosis)\n* Endometrial hiperplasia\n* Early-stage Endometrial Cancer\n* Preneoplastic lesions of the cervix\n* IA1 Cervical Cancer\n* Pelvic endometriosis\n\nExclusion Criteria:\n\n* Pregnancy\n* Liver disease\n* Coagulopathies\n* Clinical conditions contraindicating laparoscopy'}, 'identificationModule': {'nctId': 'NCT02338505', 'acronym': 'OB-ALFX', 'briefTitle': 'Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'orgStudyIdInfo': {'id': '21264/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telelap ALF-X in obese patients with gynecological disease', 'interventionNames': ['Device: Telelap ALF-X']}], 'interventions': [{'name': 'Telelap ALF-X', 'type': 'DEVICE', 'otherNames': ['ALF-X teleassisted surgery'], 'description': 'Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit.\n\nThrough the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure.', 'armGroupLabels': ['Telelap ALF-X in obese patients with gynecological disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Rome', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Scambia, Professor', 'role': 'CONTACT', 'email': 'giovanni.scambia@rm.unicatt.it', 'phone': '+39-06-30156279'}, {'name': 'Giovanni Scambia, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cristiano Rossitto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Salvatore Gueli Alletti, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Fagotti, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francesco Fanfani, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catholic University of Sacred Heart Rome,', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Salvatore Gueli Alletti, MD', 'role': 'CONTACT', 'email': 'gueliallettis@gmail.com'}, {'name': 'Salvatore Gueli Alletti, MD', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'collaborators': [{'name': 'SOFAR S.p.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Giovanni Scambia', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}