Robotic vs. Open NSM for Early Stage Breast Cancer (SP NSM)

Intuitive Surgical

Status: Enrolling

Conditions: Breast Disease; Breast Cancer; Breast Cancer Female; Breast; Breast Cancer, Early-Onset

Treatments: Procedure: Open NSM; Device: Robotic NSM

Study type: Interventional

Funder types: Industry

Identifiers

NCT05720039

ISI dV SP - NSM-01

Details and patient eligibility

About

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Full description

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Enrollment: 204 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female age 21 or older
• BMI < 30
• Candidate for an NSM procedure with immediate reconstruction
• Diagnosis of early stage brest cancer
• Breast ptosis ≤ Grade 2.
• Cup size ≤ C.

Exclusion criteria

• Previous breast surgery
• Diagnosis of metastatic breast cancer
• Prior radiation treatment to the chest
• Current smokers
• Contraindication for general anesthesia or surgery.
• Known bleeding or clotting disorder.
• Pregnant or suspected to be pregnant, or actively breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Robotic NSM with da Vinci SP

Experimental group

Description:

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Treatment:

Device: Robotic NSM

Open NSM

Active Comparator group

Description:

Subjects randomized to this arm will undergo conventional open NSM procedures

Treatment:

Procedure: Open NSM