Trials / Completed
CompletedNCT04329767
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 122 (actual)
- Sponsor
- Intuitive Surgical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IRIS 1.0 | 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. |
Timeline
- Start date
- 2020-09-18
- Primary completion
- 2023-02-03
- Completion
- 2023-08-31
- First posted
- 2020-04-01
- Last updated
- 2023-09-29
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04329767. Inclusion in this directory is not an endorsement.