NCT02938390

Brief Summary

Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

4.2 years

First QC Date

October 18, 2016

Last Update Submit

January 13, 2021

Conditions

Breast Cancer

Keywords

Nipple Sparing MastectomyUltrasound

Outcome Measures

Primary Outcomes (1)

  • Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy.

    At the time of procedure

Interventions

Ultrasound for localizing intercostal perforating vesselsPROCEDURE

Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female subjects scheduled for nipple sparing mastectomy.

You may qualify if:

  • Females 18 years of age or older
  • Planned nipple sparing mastectomy

You may not qualify if:

  • Contraindication to nipple sparing mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMITA Health Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Related Publications (2)

  • Palmer JH, Taylor GI. The vascular territories of the anterior chest wall. Br J Plast Surg. 1986 Jul;39(3):287-99. doi: 10.1016/0007-1226(86)90037-8.

    PMID: 3730674BACKGROUND

  • Lemaine V, Hoskin TL, Farley DR, Grant CS, Boughey JC, Torstenson TA, Jacobson SR, Jakub JW, Degnim AC. Introducing the SKIN score: a validated scoring system to assess severity of mastectomy skin flap necrosis. Ann Surg Oncol. 2015 Sep;22(9):2925-32. doi: 10.1245/s10434-015-4409-3. Epub 2015 Jan 30.

    PMID: 25634782BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Robert O Maganini, MD

    Amita Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)