Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-01 @ 7:57 AM
Study NCT ID:
NCT04866992
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of completion of SPrNSM through axillary incision', 'timeFrame': 'Up to 1 year', 'description': 'Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision'}, {'measure': 'Complication rate of patients requiring re-operation', 'timeFrame': 'Up to 1 year', 'description': 'Number of patients with bleeding requiring a second surgery after SPrNSM'}, {'measure': 'Complication rate of patients with infection requiring explantation of tissue expander', 'timeFrame': 'Up to 1 year', 'description': 'Number of patients with infection after surgery requiring explantation of tissue expander'}, {'measure': 'Complication rate of patients with mastectomy flap necrosis', 'timeFrame': 'Up to 1 year', 'description': 'number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score'}, {'measure': 'Operative surgery time trends with peri-operative outcomes', 'timeFrame': 'Up to 1 year', 'description': 'Measure total surgery time in relation to other outcomes in each patient'}], 'secondaryOutcomes': [{'measure': 'Patient reported outcomes', 'timeFrame': 'Up to 1 year', 'description': 'Patient satisfaction is measured using BREAST-Q. Possible scores range from 1-10 Likert scale, with higher scores indicating better/ worse outcome.'}, {'measure': 'Patient reported outcomes', 'timeFrame': 'Up to 1 year', 'description': 'Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nipple Sparing Mastectomy', 'Robot-assisted Nipple Sparing Mastectomy'], 'conditions': ['Anatomic Stage IA Breast Cancer AJCC v8', 'Anatomic Stage IB Breast Cancer AJCC v8', 'Anatomic Stage IIA Breast Cancer AJCC v8', 'Anatomic Stage II Breast Cancer AJCC v8', 'Anatomic Stage I Breast Cancer AJCC v8', 'Anatomic Stage IIB Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Ductal Carcinoma in Situ', 'Prognostic Stage I Breast Cancer AJCC v8', 'Prognostic Stage II Breast Cancer AJCC v8', 'BRCA1 Mutation', 'BRCA2 Mutation']}, 'descriptionModule': {'briefSummary': 'This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.', 'detailedDescription': 'Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy.\n\nSubjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women who undergo robotic nipple sparing mastectomy (rNSM) with reconstruction.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Subjects age \\>= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW\n\nExclusion Criteria:\n\n1. Subjects who are \\<18 years of age\n2. Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW'}, 'identificationModule': {'nctId': 'NCT04866992', 'acronym': 'SPrNSM', 'briefTitle': 'Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy', 'orgStudyIdInfo': {'id': 'STU-2019-0522'}}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Deborah Farr, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study share data of individual participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Deborah Farr', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}