NCT07006662

Brief Summary

The aim of this 6-month proof-of-concept study is to map out the chest wall perforators in relation to anatomical landmarks for partial breast reconstruction.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

May 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

May 27, 2025

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Location of vesselse

    The location of the AICAP vessels in vertical and horizontal axis using constant bony and soft tissue landmarks. This will be measured by the distance of the perforators from the anatomical landmarks

    6 months

  • Location of vessels

    The location of the MICAP vessels in vertical and horizontal axis using constant bony and soft tissue landmarks. This will be measured by the distance of the perforators from the anatomical landmarks

    6 months

  • Location of vessels

    The location of the LTAP vessels in vertical and horizontal axis using constant bony and soft tissue landmarks. This will be measured by the distance of the perforators from the anatomical landmarks

    6 months

  • Location of vessels

    The location of the LICAP vessels in vertical and horizontal axis using constant bony and soft tissue landmarks. This will be measured by the distance of the perforators from the anatomical landmarks

    6 months

Secondary Outcomes (1)

  • Variability

    6 months

Eligibility Criteria

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

The trial will be carried out at University Hospitals of North Midlands (UHNM). This will be a single centre study. Patients will be screened by the breast surgery Team for the eligibility criteria and recruited from the Breast Outpatients Clinic and marking of the perforators will be carried out on admission unit.

You may qualify if:

  • Patients undergoing elective breast surgery
  • Age ≥ 18 years
  • Female
  • BMI ≤ 30 kg/m2
  • Willing and able to give fully informed consent,
  • Willing and able to comply with the study procedures

You may not qualify if:

  • Pregnant patients
  • Previous bilateral Breast or axillary surgery
  • Undergoing bilateral oncoplastic procedure or requiring bilateral pre-operative marking
  • Undergoing breast surgery requiring pre-operative marking of some of the landmarks and has had contralateral breast or axillary surgery in the past
  • Surgery planned within 24 hours of screening for eligibility
  • Known history of allergy or contact dermatitis to ultrasound gels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 5, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations