Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT05565157
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flapless Zygomatic Implants Robot-assisted Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation rate between theoretical intraoperative position and post-operative zygomatic implants position', 'timeFrame': 'one day', 'description': 'The accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['zygomatic implant', 'robotic', 'flapless', 'mini-invasive', 'ROSA', 'immediate loading'], 'conditions': ['Zygomatic Implant', 'Robotic']}, 'descriptionModule': {'briefSummary': 'Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.\n\nHowever, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.\n\nThis approach is technically difficult, and is performed by an experienced surgeon.\n\nThe development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.\n\nPath planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from Maxillary edentulism with severe bone resorption\n* Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction\n* Patients suffering from post-maxillectomy buccosinusal communication.\n* Age ≥ 18 years old\n* Having signed the informed consent\n\nExclusion Criteria:\n\n* Patients suffering from chronic sinusitis\n* Patients refusing ROSA robot-guided surgery (unsigned informed consent).\n* Pregnant and nursing women'}, 'identificationModule': {'nctId': 'NCT05565157', 'acronym': 'ROSA-ZYGOMA', 'briefTitle': 'Flapless Zygomatic Implants Robot-assisted Placement', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Flapless Zygomatic Implants Robot-assisted Placement', 'orgStudyIdInfo': {'id': 'PI2020_843_0076'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zygomatic implants', 'type': 'PROCEDURE', 'description': 'A robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie Testellin, Pr', 'role': 'CONTACT', 'email': 'testelin.sylvie@chu-amiens.fr', 'phone': '03 22 08 90 50'}, {'name': 'Jérémie BETTONI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michel LEFRANC, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthieu OLIVETTO, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Sylvie TESTELIN, Pr', 'role': 'CONTACT', 'email': 'sylvie.testelin@chu-amiens.fr', 'phone': '03.22.08.90.50'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}