NCT05109182

Brief Summary

To establish whether surgical planning using virtual 3D modelling (Innersight 3D) improves the outcome and cost-effectiveness of RAPN, allowing more patients to benefit from minimally-invasive procedures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

October 26, 2021

Last Update Submit

October 26, 2021

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

  • Total Console time

    This is the time from the start of the robotic operation (arms start moving inside the abdomen) until the end of the robotic operation (arms have been taken out of the abdomen) and will be recorded using the robotic system

    18 months

Secondary Outcomes (16)

  • Artery preparation time (mins)

    18 months

  • Tumour preparation time (mins)

    18 months

  • Tumour resection time (mins)

    18 months

  • Hilar clamping technique

    18 months

  • Extirpative technique

    18 months

  • +11 more secondary outcomes

Study Arms (2)

Intervention (3D model + CT for surgical planning)

EXPERIMENTAL

Patients in this arm will receive a 3D model which will be used in addition to the CT scan for surgical planning.

Device: Innersight3D

Control (CT for surgical planning)

NO INTERVENTION

Patients in this arm will only have the a CT scan used for surgical planning.

Interventions

Innersight3DDEVICE

Innersight3D generates a virtual interactive 3D model of the CT scan.

Intervention (3D model + CT for surgical planning)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-80 years; Agreement at Multidisciplinary team meeting that this patient could undergo robotic-assisted partial nephrectomy.
  • Willing and able to provide written informed consent. RENAL score (tumour complexity) \>= 8. Received contrast enhanced abdominal preoperative CT scan. Ability to understand and speak English.

You may not qualify if:

  • Do not consent for robotic assisted partial nephrectomy; Chose to have treatment outside one of the NHS trial sites. Participation in other clinical studies that would potentially confound this study; Have a horseshoe, a solitary kidney or bilateral kidney tumours; Lack of willingness to allow personal medical imaging data to be used for generating a 3D model;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Lorenz Berger, PhD

CONTACT

07979067365lorenz@innersightlabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The following will be blinded: Chief Investigator, Senior Statistician, Research Nurses, Trial Steering Committee The following will be unblinded: Principal Investigators at site, Trial Manager/monitor, Junior Statistician, Trial Participants, Treating clinicians, Data Monitoring Committee
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This RCT, is a multi-centre main trial and will recruit patients selected for minimally-invasive robotic-assisted renal cancer surgery during the enrolment period. The study will compare current surgical planning method to planning with the addition of virtual 3D models in randomised patient groups. There are no clinical treatment changes/interventions in addition to the standard-of-care procedures. Participants will have 3D models of their anatomy built, clinical team and participant feedback will be obtained in the form of a survey, and the measurability of the key trial outcomes will be assessed as outlined below. Patient participation in the trial is expected to take no longer than 9 weeks, including a 4-week follow-up, from the initial participant information meeting. Methods used to assess outcomes will employ medical data analysis, participant opinion and observational measurements.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

January 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share