Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT07062458
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
Sponsor:
Candiolo Cancer Institute - IRCCS
Organization:
Study Overview
Official Title:
NIPSENSE - A Comparative Study of Nipple and Skin Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, and Robotic Techniques
Status:
RECRUITING
Status Verified Date:
2025-07
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:
NIPSENSE
Brief Summary:
The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM). The study will compare three types of NSM: conventional, endoscopic, and robotic.
The main question it aims to answer is:
How much nipple sensation do participants keep after each type of surgery?
Researchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation.
Participants will:
Have NSM using one of the three surgical approaches
Receive breast reconstruction with an implant during the same surgery
Complete nipple sensation tests before and at 1, 3, and 6 months after surgery
Answer surveys about their quality of life and body image
Provide surgical tissue for analysis (as part of the planned procedure)
The main question it aims to answer is:
How much nipple sensation do participants keep after each type of surgery?
Researchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation.
Participants will:
Have NSM using one of the three surgical approaches
Receive breast reconstruction with an implant during the same surgery
Complete nipple sensation tests before and at 1, 3, and 6 months after surgery
Answer surveys about their quality of life and body image
Provide surgical tissue for analysis (as part of the planned procedure)
Detailed Description:
The NIPSENSE study is a prospective, single-center study comparing how well nipple sensation is preserved after three types of nipple-sparing mastectomy (NSM): Conventional NSM (C-NSM), Endoscopic NSM (E-NSM), and Robotic NSM (R-NSM). The goal is to better understand the sensory and quality-of-life outcomes associated with each technique.
A total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.
The study will also evaluate:
Surgical complications (e.g., infection, bleeding, skin necrosis)
Patient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires
Tissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery
This study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.
A total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.
The study will also evaluate:
Surgical complications (e.g., infection, bleeding, skin necrosis)
Patient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires
Tissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery
This study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 00043/2025 | REGISTRY | Comitato Etico Città della Salute e della Scienza di Torino | View |