Multimodal Augmented Reality for Operative Guidance in Oncoplastic Breast Surgery

ISRCTN	ISRCTN16306571
DOI	https://doi.org/10.1186/ISRCTN16306571
IRAS number	306799
Secondary identifying numbers	IRAS 306799

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

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

Study design	Multi-centre interventional non-control trial in patients undergoing oncoplastic breast procedures
Primary study design	Interventional
Secondary study design
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Multimodal Augmented Reality for Operative Guidance in Oncoplastic Breast Surgery
Study acronym	MAROG - OBS
Study hypothesis	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
Condition	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	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.
Secondary outcome measures	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.
Overall study start date	10/02/2022
Overall study end date	31/12/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100
Participant 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.
Participant 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.
Recruitment start date	31/05/2022
Recruitment end date	31/12/2025

Locations

Countries of recruitment

England
United Kingdom

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

Sponsor information

Imperial College London
Industry

Research Governance and Integrity Team
Imperial College London and Imperial College Healthcare NHS Trust
Room 215, Level 2
Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom

Email	rgit@imperial.ac.uk
Website	https://www.medicalisight.com/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/04/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	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.
IPD sharing plan	Not expected to be made available.

Editorial Notes

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