New 3D guidance system aims to sharpen kidney cancer surgery
NCT ID NCT06945640
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a surgical navigation system called RUS NE that turns CT scans into 3D models to help guide robot-assisted kidney tumor removal. Researchers will compare outcomes in 80 patients who use the system versus those who don't, looking at how much tissue is removed and surgery time. The goal is to see if the system makes surgery more precise and safer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RUS NE surgical navigation system (a device that creates 3D models from CT scans to guide surgery)
- What this could lead to
- If successful, this system could help surgeons remove kidney tumors more precisely, potentially preserving more healthy kidney tissue and improving recovery.
- What could go wrong
- This is a small, early-stage study (80 participants) comparing outcomes with and without the system. It may not show a clear benefit, and results may not apply to all hospitals or patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria \[Experimental Group\] 1. Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years. 2. Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form. 3. Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging. 4. Patients with a RENAL Nephrometry Score between 4 and 12. \[Control Group\] 1. Patients diagnosed with renal cancer who underwent robot-assisted partial nephrectomy using the standard surgical method at the institution between January 1, 2020, and January 23, 2025. 2. Patients aged between 19 and 79 years. 3. Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging. 4. Patients with a RENAL Nephrometry Score between 4 and 12. Exclusion Criteria \[Experimental Group\] 1. Patients who do not consent to participate in the clinical trial. 2. Patients whose CT examination does not follow the required protocol for image analysis. 3. Patients with a history of abdominal surgery likely to cause severe adhesions. 4. Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT. 5. Patients scheduled for bilateral nephrectomy. 6. Patients requiring simultaneous resection of other organs in addition to nephrectomy. 7. Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment. 8. Patients with severe renal dysfunction at the time of screening (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR \<60). 9. Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI. 10. Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate. 11. Patients who have participated in or are scheduled to participate in another clinical trial (medical device or pharmaceutical) within four weeks prior to screening. 12. Patients deemed unsuitable for clinical trial participation at the investigator's discretion. 13. Patients whose CT images are not suitable for generating 3D images for use with the investigational medical device. \[Control Group\] 1. Patients whose CT data are unavailable. 2. Patients with a history of abdominal surgery with expected or confirmed severe adhesions. 3. Patients with a solitary kidney or horseshoe kidney. 4. Patients who have undergone bilateral nephrectomy. 5. Patients who have undergone simultaneous resection of other organs in addition to nephrectomy. 6. Patients with renal dysfunction (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR \<60).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A camera that sees invisible light could guide kidney tumor removal
- A Pre-Surgery Tune-Up: could it help older adults recover faster?
- Can a national registry reveal the secrets to better kidney surgery?
- Electric pulses vs. pelvic tumors: a new hope when surgery fails?
- A million cancer Patients' genetic data could unlock better treatments