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New 3D guidance system aims to sharpen kidney cancer surgery

NCT ID NCT06945640

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

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

20 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Asan Medical Center

    Seoul, South Korea

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