Robot Assisted Mastectomy Via Axillary Way With Areola Co... | NCT02673268

Studies
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction

NCT02673268

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Oct 12, 2017Actual

Enrollment

80Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Mastectomy
Da Vinci Robot Xi

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015/2250	Other Identifier	CSET number

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2015Actual

Primary Completion Date

Nov 2019Estimated

Completion Date

Nov 2020Estimated

First Submitted Date

Feb 1, 2016

First Submission Date that Met QC Criteria

Feb 2, 2016

First Posted Date

Feb 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.

The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.

The aim is also to study the rate of complications, cosmetic results and quality of life.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Label	Type	Description	Intervention Names
Patients with breast cancer	Experimental		Procedure: Mastectomy Device: Da Vinci Robot Xi

Name	Type	Description	Arm Group Labels	Other Names
Mastectomy	Procedure		Patients with breast cancer
Da Vinci Robot Xi

Measure	Description	Time Frame
Rate of necrosis		Assessed up to 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery:

Disease located more than 2cm of the areola on the clinical and paraclinical evaluation
Patients with indication of total mastectomy
Patients looking for immediate reconstruction 3. In case of prophylactic surgery
Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system

Exclusion Criteria:

Patients with a high risk of skin necrosis
Planned post operative radiotherapy
Patients with an historic of breast surgery on the side that needs to be operated
Pregnant or breastfeeding women
Persons deprived of liberty
Persons not able to undergo medical follow up due to geographical, social or psychic reasons

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Sarfati, MD	Contact	0142114384	+33	Benjamin.sarfati@gustaveroussy.fr
Stefan Michels, PhD	Contact			Stefan.michiels@gustaveroussy.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gustave Roussy Cancer Campus	Recruiting	Villejuif	Val de Marne	94805	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29959612	Derived	Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases