Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT06335550
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical and Patient Reported Outcomes in Robotic Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-05', 'size': 785756, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-08T05:13', 'hasProtocol': True}, {'date': '2023-05-03', 'size': 704077, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-08T05:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Outcomes - Operative parameters', 'timeFrame': 'Postoperative Day 0-1', 'description': '\\- Operative parameters (in terms of docking time/console time and total operative time - defined as time taken from axilla staging procedure, robot docking time, console time, closure and time taken for reconstruction, if applicable'}, {'measure': 'Surgical Outcomes - Length of stay (days)', 'timeFrame': 'Postoperative 30 days', 'description': '\\- Length of stay (days)'}, {'measure': 'Surgical Outcomes- 30-days morbidity/complications', 'timeFrame': 'Postoperative 30 days', 'description': '\\- 30-days morbidity/complications'}], 'secondaryOutcomes': [{'measure': 'Oncologic outcomes', 'timeFrame': 'Postoperative 2 weeks until final histopathology results are available', 'description': 'Short-term oncologic outcomes, such as positivity of margins'}, {'measure': 'Learning curve', 'timeFrame': 'Postoperative up to 2 years throughout study recruitment', 'description': 'Learning curve analysis using cumulative sum (CUSUM) method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Minimally invasive breast surgery', 'endoscopic breast surgery', 'robotic breast surgery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.\n\nIn terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.\n\nTo date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.\n\nThe aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM.\n\nFor patients with breast cancer (invasive or DCIS), selection criteria include but not limited to:\n\n1. Early breast cancer\n2. Tumor size less than 5 cm\n3. No evidence of lymph node metastases\n4. No evidence of skin or chest wall invasion.\n\nExclusion Criteria:\n\n1. Extensive axillary lymph node metastasis (Stage 3B or later)\n2. Heavy smokers (\\>20 cigarettes a day)\n3. High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)\n4. Poor performance status or high risk for anaesthesia (ASA 3 and above)\n5. Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)'}, 'identificationModule': {'nctId': 'NCT06335550', 'briefTitle': 'Surgical and Patient Reported Outcomes in Robotic Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia', 'orgStudyIdInfo': {'id': '2021/2680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Robotic mastectomy', 'description': 'All consecutive cases of robotic mastectomy over the study duration', 'interventionNames': ['Procedure: Robotic mastectomy']}], 'interventions': [{'name': 'Robotic mastectomy', 'type': 'PROCEDURE', 'description': 'Robotic mastectomy with or without reconstruction', 'armGroupLabels': ['Robotic mastectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Chi Wei Mok', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Clinical Assistant Professor', 'investigatorFullName': 'Mok Chi Wei', 'investigatorAffiliation': 'Changi General Hospital'}}}}