NCT07236359: Reborn-i

Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

Not yet recruiting NA Last updated 19 November 2025

What this trial tests

NA trial testing Intervention in Breast Reconstruction in 108 participants. Not yet recruiting.

Timeline

31 December 2025

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	Beaumont Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	108
Start date	31 December 2025
Primary completion	31 December 2027
Estimated completion	31 December 2028

Drugs / interventions tested

• Intervention
• Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Conditions studied

• Breast Reconstruction — all drugs for Breast Reconstruction →
• Breast Cancer — all drugs for Breast Cancer →
• Hereditary Breast/Ovarian Cancer (brca1, brca2) — all drugs for Hereditary Breast/Ovarian Cancer (brca1, brca2) →
• Robotic Surgery — all drugs for Robotic Surgery →

Sponsor

Beaumont Hospital

Who can join

18 and older, female only, with Breast Reconstruction or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.