Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT04726904
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-01', 'studyFirstSubmitDate': '2021-01-23', 'studyFirstSubmitQcDate': '2021-01-23', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance lead to nerve', 'timeFrame': '1 week', 'description': 'The exact distance (mm) will be assessed from the lead to the nerve'}], 'secondaryOutcomes': [{'measure': 'Neuroforamen', 'timeFrame': '1 week', 'description': 'The inserted neuroforamen will be assessed.'}, {'measure': 'Sacral fascia', 'timeFrame': '1 week', 'description': 'A perforation throw the sacral fascia will be noted.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Faecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '33211205', 'type': 'BACKGROUND', 'citation': 'Muller C, Reissig LF, Argeny S, Weninger WJ, Riss S. Standardized fluoroscopy-guided implantation technique enables optimal electrode placement in sacral neuromodulation: a cadaver study. Tech Coloproctol. 2021 Feb;25(2):215-221. doi: 10.1007/s10151-020-02364-w. Epub 2020 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.\n\nIn this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.', 'detailedDescription': 'Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.\n\nHowever, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.\n\nIn this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.\n\nThe results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cadaver study\n* All of these individuals had donated their bodies to medical education and research in form of an informed consent.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04726904', 'briefTitle': 'Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study', 'orgStudyIdInfo': {'id': '2219/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Conventional lead placement', 'description': 'The cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique.', 'interventionNames': ['Procedure: Sacral neuromodulation in conventional implantation technique']}], 'interventions': [{'name': 'Sacral neuromodulation in conventional implantation technique', 'type': 'PROCEDURE', 'description': 'Sacral neuromodulation is implanted with the patients in a prone position, then the insert point of the needle is decided according to anatomical landmarks; afterwards, the lead will be inserted.', 'armGroupLabels': ['Conventional lead placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christopher Dawoud, MD', 'role': 'CONTACT', 'email': 'christopher.dawoud@meduniwien.ac.at'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Christopher Dawoud, MD', 'role': 'CONTACT', 'email': 'christopher.dawoud@meduniwien.ac.at', 'phone': '0043660 280 48 39'}], 'overallOfficials': [{'name': 'Christopher Dawoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.univ.', 'investigatorFullName': 'Dr. Christopher Dawoud', 'investigatorAffiliation': 'Medical University of Vienna'}}}}