Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-06 @ 12:59 PM
Study NCT ID:
NCT01705405
Status:
TERMINATED
Last Update Posted:
2016-10-18
First Post:
2012-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'due to a problem of device', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2012-10-05', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)', 'timeFrame': '1year'}], 'secondaryOutcomes': [{'measure': 'Percent of data(ultrasound and endoscopic) on which the merging works', 'timeFrame': '1year'}, {'measure': 'Percent of accurate merging', 'timeFrame': '1year', 'description': 'the merging is accurate if its error is under 5mm'}, {'measure': 'Percent of mistaken segmentation of the vesical neck in the endoscopic image', 'timeFrame': '1year', 'description': 'The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'prostate'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cic-it-grenoble.fr/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Visualize surgical needles inserted in the prostate, under the ultrasound modality.', 'detailedDescription': 'In order to help the surgeon to remove the prostate during a laparoscopic intervention, our goal is to provide an innovative medical device that merges intra-operative ultrasound and endoscopic images.\n\nWe have already achieved the proof of concept of a device that merges ultrasound and endoscopic images. The objectives of this clinical trial are to accompany the maturation of the fusion device and to make the initial assessments of its Medical Service.\n\nThe main difficulty is to visualize markers (surgical needles) under both modalities , in order to merge them.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* of-age patient\n* patient for whom a radical prostatectomy is planned\n* patient with a prostate volume between 30g and 100g\n* patient affiliated to the social security or equivalent\n* Written informed consent\n\nExclusion Criteria:\n\n* contraindication\n* patient who has undergone a significant prostate resection\n* patient who has undergone a prostate irradiation\n* patient concerned by the L1121-6 à 8 of the health public code'}, 'identificationModule': {'nctId': 'NCT01705405', 'acronym': 'FEE', 'briefTitle': 'Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'DCIC 12 06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'medical device', 'description': 'medical device to acquire ultrasound and endoscopic images during surgery', 'interventionNames': ['Device: Software for acquiring ultrasound and endoscopic images']}], 'interventions': [{'name': 'Software for acquiring ultrasound and endoscopic images', 'type': 'DEVICE', 'description': 'Use of a medical device to acquire ultrasound and endoscopic images', 'armGroupLabels': ['medical device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Isère', 'country': 'France', 'facility': 'Urology, University hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Alexandre Long, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdministrateurCIC', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIMC-IMAG', 'class': 'OTHER'}, {'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'AdministrateurCIC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}