Kidney CancerNCT04329767
A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy
An observational study of Kidney Cancer, run by Intuitive Surgical at 2 sites in United States.
Trial summary
This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- IRIS 1.0
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with kidney cancer who will undergo robotic-assisted partial or robotic-assisted radical nephrectomy.
Who may be able to join
- Subject is 18 years or older
- Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon
- Subjects who has had or plan to have a CT scan (with IV contrast medium)
Who cannot join
- Subject has a solitary or horseshoe kidney
- Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney
- Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery
- Subject with renal vein tumor thrombus
- Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time)
- Metastatic disease with life expectancy of less than 1 year
Show all 9Show fewer
- Pregnant or suspect pregnancy
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hackensack University Medical Center
Edison, New Jersey, 08837
University of Rochester Medical Center
Rochester, New York, 14642
About this study
This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for nephrectomy. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.
- Conditions
- Kidney Cancer
- Being tested
- IRIS 1.0
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRIS 1.0Device
Intuitive's IRIS 1.0 system is a software only device and service intended to create and deliver segmented image studies (3D anatomical models) based on patients computed tomography (CT) scans. It is intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images.
| Study group | Role | What they receive |
|---|---|---|
| IRIS Arm | Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively Receives: Device: IRIS 1.0 | |
| CT Arm | Utilize only the standard 2D CT scan preoperatively and intraoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation
- Interpretation of the anatomy
- Procedure efficiency,
- Sufficient information to use intraoperatively, and
- Impact on the clinical practice
Measured: Intra-operative
Secondary outcomes (1)
Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning
- Interpretation of the anatomy,
- Sufficient information to use preoperatively, and
- Confidence in completing the planned procedure.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start18 Sep 2020
- Primary completion3 Feb 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329767
- Sponsor's protocol ID
- ISI-IRIS-002
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2020
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy
- ClinicalTrials.gov ID
- NCT04329767
- Acronym / sponsor ID
- ISI-IRIS-002
- Conditions
- Kidney Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for nephrectomy. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRIS Arm | – | Device: IRIS 1.0Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively |
| CT Arm | – | –Utilize only the standard 2D CT scan preoperatively and intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with kidney cancer who will undergo robotic-assisted partial or robotic-assisted radical nephrectomy.
Key inclusion criteria (3 listed)
- Subject is 18 years or older
- Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon
- Subjects who has had or plan to have a CT scan (with IV contrast medium)
Key exclusion criteria (9 listed)
- Subject has a solitary or horseshoe kidney
- Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney
- Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery
- Subject with renal vein tumor thrombus
- Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRIS 1.0Intuitive's IRIS 1.0 system is a software only device and service intended to create and deliver segmented image studies (3D anatomical models) based on patients computed tomography (CT) scans. It is intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. | Device | IRIS Arm |
Primary outcome
Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation
Time frame: Intra-operative
1. Interpretation of the anatomy 2. Procedure efficiency, 3. Sufficient information to use intraoperatively, and 4. Impact on the clinical practice
1 secondary outcome
Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning
Time frame: Preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by Intuitive Surgical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.