Multimodal Augmented Reality for Operative Guidance in Oncoplastic Breast Surgery

ISRCTN	ISRCTN16306571
DOI	https://doi.org/10.1186/ISRCTN16306571
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	306799
Protocol serial number	IRAS 306799
Sponsor	Imperial College London
Funder	Investigator initiated and funded

Submission date: 07/11/2024
Registration date: 11/11/2024
Last edited: 11/11/2024

Recruitment status: Recruiting
Overall study status: Deferred
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

Contact information

Mr Daniel Leff
Principal investigator

Department of Breast Surgery
First Floor
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

ORCID ID	0000-0002-5310-1046
Email	d.leff@imperial.ac.uk

Dr Philip Pratt
Public, Scientific

Medical iSight (UK) Ltd
9th Floor
107 Cheapside
London
EC2V 6DN
United Kingdom

Email	pjp@medicalisight.com

Study information

Primary study design	Interventional
Study design	Multi-centre interventional non-control trial in patients undergoing oncoplastic breast procedures
Secondary study design
Study type	Participant information sheet
Scientific title	Multimodal Augmented Reality for Operative Guidance in Oncoplastic Breast Surgery
Study acronym	MAROG - OBS
Study objectives	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Ethics approval(s)	Approved 10/02/2022, London - Queen Square Research Ethics Committee (RA NRES Centre Manchester, Barlow House, 3rd floor, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8225; queensquare.rec@hra.nhs.uk), ref: 21/PR/1795
Health condition(s) or problem(s) studied	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention type	Other
Primary outcome measure(s)	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Key secondary outcome measure(s)	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Completion date	31/12/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100
Key inclusion criteria	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Key exclusion criteria	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Date of first enrolment	31/05/2022
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Charing Cross Hospital

Department of Breast Surgery
1st Floor, Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

St George's University Hospital

Department of Plastic and Reconstructive Surgery
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Not expected to be made available.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/11/2024: Study's existence confirmed by the HRA.