Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-24 @ 7:44 AM
Study NCT ID:
NCT07236359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
Sponsor:
Beaumont Hospital
Organization:
Study Overview
Official Title:
A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reborn-i
Brief Summary:
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast.
However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries.
This study will compare:
* Robotic nipple-sparing mastectomy
* Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients.
Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.
However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries.
This study will compare:
* Robotic nipple-sparing mastectomy
* Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients.
Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: