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3D Virtual Models as an Adjunct to Preoperative Surgical Planning

NCT03606044 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2020-02-12

No results posted yet for this study

Summary

This study aims to determine the feasibility of undertaking a future definitive RCT to evaluate the clinical effectiveness of complementing existing medical scans with a patient-specific interactive 3D virtual model of the patient's body to assist the surgeon with planning for the operation in the best way possible. Renal cancer patients receive a tri-phasic CT scan as routine practice, thus if the standard imaging protocols are followed, there should be ample imaging data available for 3D model creation.

This study is a single-site, single-arm, unblinded, prospective, feasibility study aiming to recruit 24 participants from the Royal Free Hospital that are scheduled for robotic-assisted partial nephrectomy. Consenting participants will be recruited over a 6-month period, and interactive 3D virtual models of their anatomy will be generated. These models will be used to aid surgeon-patient communications and to plan for the operation. This study will determine whether a definitive RCT of virtual 3D models as an adjunct to surgery planning is feasible with respect to: recruitment of local authorities and patients; ensuring staff can be adequately trained to deliver programmes within specified timeframes; and assessment of the measurability of key surgical outcomes.

Conditions

  • Kidney Neoplasms
  • Surgical Oncology

Interventions

DEVICE

3D-models

The study radiologist will generate a patient-specific virtual 3D model of the participant's body from their pre-operational medical scans (CT, and MRI if available) using regulated commercial medical image analysis software, specifically Osirix MD 9.0 (Pixmeo, Geneva, Switzerland).(Rosset et al. 2004) The CRFw checks that the medical scan segmentation is accurate and validates the virtual 3D model. The surgeon checks that the medical scan segmentation is accurate and validates the virtual 3D model. The surgeon uses all available medical scan data, and the virtual 3D model as an adjunct, to assess the patient anatomy and plan the operation accordingly

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER

  • Dr Eoin R Hyde

    lead INDUSTRY

Principal Investigators

  • Faiz H Mumtaz, MBBS, MD · Royal Free Hospital NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-07-31
Completion
2019-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606044 on ClinicalTrials.gov