Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT07123051
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
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': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary safety outcome', 'timeFrame': 'up to 30 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 device related conversion to an open or fully laparoscopic surgical approach.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Right Colectomy']}, '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 right colectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing a right colectomy for malignant or benign indication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\> 18 years\n* Patient agrees to perform the 30-day follow-up assessment as per standard of care\n\nExclusion Criteria:\n\n* History of radiotherapy on the target surgical area\n* Patients with distant metastasis\n* Any planned concomitant procedures\n* History of major abdominal surgery'}, 'identificationModule': {'nctId': 'NCT07123051', 'acronym': 'RACER', 'briefTitle': 'Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Distalmotion SA'}, 'officialTitle': 'Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System', 'orgStudyIdInfo': {'id': '2025-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'right colectomy', 'type': 'DEVICE', 'description': 'Robotic-assisted right colectomy with the DEXTER robotic surgery system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36000', 'city': 'Châteauroux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexis Vinet, MD', 'role': 'CONTACT', 'email': 'Alexis.Vinet@ch-chateauroux.fr', 'phone': '+33 2 54 29 60 07'}], 'facility': 'CH Châteauroux - Le Blanc', 'geoPoint': {'lat': 46.81248, 'lon': 1.69362}}, {'zip': '17100', 'city': 'Saintes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hubert Mignot, MD', 'role': 'CONTACT', 'email': 'hubert.mignot@gh-saintesangely.fr', 'phone': '+33546951516'}], 'facility': "Groupe Hospitalier Saintes - Saint-Jean-d'Angély, Saintes", 'geoPoint': {'lat': 45.74742, 'lon': -0.63489}}, {'zip': '81379', 'city': 'Munich', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Mussack, MD', 'role': 'CONTACT', 'email': 'bauchzentrum-akms@artemed.de', 'phone': '+49 89 72440 224'}], 'facility': 'Artemed Klinikum München Süd', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], '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'}}}}