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

Intuitive Surgical logo

Intuitive Surgical

Status

Active, not recruiting

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)

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

Trial contacts and locations

15

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Central trial contact

Brittanny Boyer

Data sourced from clinicaltrials.gov

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