Cryobiopsy of the kidneys (including renal pelvis): clinical in vivo evaluation in the human upper urinary tract.

Cryobiopsy of the kidneys (including renal pelvis): clinical in vivo evaluation in the human upper urinary tract. - Cryo in vivo

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025620

Enrollment

Registered

2022-03-07

Start date

2022-03-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C65 C66

Interventions

Group 1: Endoscopic ureterorenoscopic biopsy of tumor tissue from the renal pelvic caliceal system using standard instrumentation followed by cryobiopsy technique. Comparison of results in terms of bi

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with the image morphological correlate of a renal pelvic tumor in the imaging diagnosis 5 mm on diagnostic imaging will undergo endoscopic specimen biopsy to confirm the diagnosis as part of the preoperative diagnostic workup. - Signed consent form

Exclusion criteria

Exclusion criteria: - Patients with single kidney - Patients with pronounced bleeding tendency - Patients with transplant kidneys - Patients with high-grade chronic renal failure or functional single kidney - Patients with acute urinary tract infection - Patients who are younger than 18 years - Patients who are pregnant - Patients who are not capable of giving their own consent - Patients who are already participating in another study

Design outcomes

Primary

Measure	Time frame
The diagnosis can be made on tissue taken from the human upper urinary tract by cryobiopsy in vivo.	—

Secondary

Measure	Time frame
- Feasibility of cryobiopsy in vivo (with number of attempts until a biopsy specimen was macroscopically obtained). - Increase in diagnostic rate using cryobiopsy with the cryoprobe (CB11) compared to the standard biopsy procedure for human urothelial tumors. - Assess the safety of cryobiopsy sampling with the cryoprobe (CB11). o Bleeding (recording by severity). o Other complications (perforation, injury to the renal pelvic caliceal system, occurrence of infections). - Recording of histo-pathological quality and quantity of CB11 (largest cross-sectional area, percentage of artifacts, histo-morpho score/histo-pathological assessability of tissue, representativeness). o And comparison to the respective standard biopsy procedure. Renal pelvis: standard biopsy forceps (FBx) and dormia basket. - Acquisition of histo-pathological assessment of total tissue (biopsy removal/organ removal) in relation to diagnostic rate.	—

Measure

Time frame

- Feasibility of cryobiopsy in vivo (with number of attempts until a biopsy specimen was macroscopically obtained). - Increase in diagnostic rate using cryobiopsy with the cryoprobe (CB11) compared to the standard biopsy procedure for human urothelial tumors. - Assess the safety of cryobiopsy sampling with the cryoprobe (CB11). o Bleeding (recording by severity). o Other complications (perforation, injury to the renal pelvic caliceal system, occurrence of infections). - Recording of histo-pathological quality and quantity of CB11 (largest cross-sectional area, percentage of artifacts, histo-morpho score/histo-pathological assessability of tissue, representativeness). o And comparison to the respective standard biopsy procedure. Renal pelvis: standard biopsy forceps (FBx) and dormia basket. - Acquisition of histo-pathological assessment of total tissue (biopsy removal/organ removal) in relation to diagnostic rate.

—

Countries

Germany

Contacts

Public ContactSaha Dedic

Studiensekretariat, Universitätsklinikum Ulm, Kliniken am oberen Eselsberg

saha.dedic@uniklinik-ulm.de0731 500 58080

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026