Clinical trial · Observational
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
NCT04329767CI-TRIAL-00070068completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IRIS 1.0 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- IRIS Arm
- description
- Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively
- interventionNames
- Device: IRIS 1.0
- label
- CT Arm
- description
- Utilize only the standard 2D CT scan preoperatively and intraoperatively
Primary outcomes (1)
- measure
- Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation
- timeFrame
- Intra-operative
- description
- 1. Interpretation of the anatomy 2. Procedure efficiency, 3. Sufficient information to use intraoperatively, and 4. Impact on the clinical practice
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is 18 years or older 2. Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon 3. Subjects who has had or plan to have a CT scan (with IV contrast medium) Exclusion Criteria: 1. Subject has a solitary or horseshoe kidney 2. Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney 3. Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery 4. Subject with renal vein tumor thrombus 5. Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time) 6. Metastatic disease with life expectancy of less than 1 year 7. Pregnant or suspect pregnancy 8. 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 9. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
References
Publications (0)
Data not yet available
No reference posted for this study.