Breast: Recovery After Axillary Node Clearance - Evaluati... | NCT03635723

Studies
Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)

NCT03635723

Sponsor

Imperial College London

Status

Unknown status

Last Update Posted

Apr 11, 2024Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Breast Cancer
Mobility Limitation

Interventions

Activity monitor

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2018Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Aug 15, 2018

First Submission Date that Met QC Criteria

Aug 15, 2018

First Posted Date

Aug 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2024

Last Update Posted Date

Apr 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical		Having undergone a procedure in hospital	Device: Activity monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Activity monitor	Device	Technology allowing measurement of physical activity	Surgical

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arm movements	Arm movements as measured by wearable sensor	Post-operative for 2-4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast or axillary surgery

Exclusion Criteria:

Other diagnosed movement disorder
Cannot consent due to language or capacity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing breast surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard M Kwasnicki, PhD MRCS	Contact	+44 (0) 20 759 48904		rmk107@ic.ac.uk

Overall Officials

Name	Affiliation	Role
Richard Kwasnicki	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial College Healthcare NHS Trust	Recruiting	London		W2 1NY	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41797200	Derived	Kwasnicki RM, de Galbert L, Poon K, Giannas E, Graham J, Dunne J, Gokani V, Henry FP, Hunter JE, Williams G, Leff D, Wood SH. Validating a digital recovery tool for autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2026 Apr;115:225-233. doi: 10.1016/j.bjps.2026.02.016. Epub 2026 Feb 21.
40120218	Derived

ID	Term
D001943	Breast Neoplasms
D051346	Mobility Limitation
D009043	Motor Activity

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D000076251	Wearable Electronic Devices
D055615	Electrical Equipment and Supplies