Renal Cell Carcinoma (RCC)CASPIANNCT06722807
ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
A study testing sutureless, clampless partial nephrectomy in people with Renal Cell Carcinoma (RCC), run by University of Florida at 1 site in United States.
Trial summary
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- sutureless, clampless partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to May 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age.
- Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
- Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician or approved by the Principal Investigator] may be included).
- A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus.
- Adequate laboratory test results, including:
- Platelets > 50,000/µL
Show all 10Show fewer
- Hemoglobin > 9.0 g/dL
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 2 weeks after surgery to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 2 weeks following surgery.
Who cannot join
- Bleeding disorder (any congenital bleeding diathesis)
- Liver dysfunction with end stage liver disease as determined by the treating investigator
- Presence of renal vein thrombus
- End stage renal disease (eGFR < 15 using Cockcroft-gault formula or receiving renal replacement therapy (i.e. dialysis))
- Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 2 weeks after surgery.
- Subjects who are confirmed to be pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied.
Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- sutureless, clampless partial nephrectomy
- Keywords
- partial nephrectomy, renal hilar clamping, renal masses, sutureless, clampless, kidney
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutureless, clampless partial nephrectomyProcedure or surgery
All subjects will undergo a clampless, sutureless robotic partial nephrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Clampless, sutureless robotic partial nephrectomy | Experimental | Not described Receives: Procedure: sutureless, clampless partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive margin rate
Determine the positive margin rate, as measured on the pathology report 2-3 weeks post-surgery.
Measured: 2-3 weeks post-surgery
Transfusion rate
Determine the transfusion rate, as measured approximately 4 weeks post-surgery via review of patient medical records.
Measured: 4 weeks post-surgery
Secondary outcomes (5)
Renal dysfunction (1 day post-surgery)
Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 1-day post-surgery.
Measured: 1 day post-surgery
Renal dysfunction (2-3 weeks post-surgery)
Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 2-3 weeks post-surgery.
Measured: 2-3 weeks post-surgery
Renal dysfunction (6 months post-surgery)
Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 6 months post-surgery.
Measured: 6 months post-surgery
Estimated blood loss
Determine the estimated blood loss, as determined on the operative report.
Measured: at time of partial nephrectomy
Need for ischemia
Determine how many subjects have a need for ischemia, as determined by need to clamp or not.
Measured: at time of partial nephrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start10 Jun 2025
- Primary completionNov 2027 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: Interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Crispen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722807
- Sponsor's protocol ID
- UF-GU-011
- Other IDs
- IRB202500072
- Acronym
- CASPIAN
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)
- ClinicalTrials.gov ID
- NCT06722807
- Acronym / sponsor ID
- CASPIAN / UF-GU-011
- Conditions
- Renal Cell Carcinoma (RCC)
- Keywords
- partial nephrectomy, renal hilar clamping, renal masses, sutureless, clampless, kidney
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Interim analysis
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied.
Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clampless, sutureless robotic partial nephrectomy | Experimental | Procedure: sutureless, clampless partial nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults ≥ 18 years of age.
- Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
- Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician or approved by the Principal Investigator] may be included).
- A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus.
- Adequate laboratory test results, including:
Key exclusion criteria (8 listed)
- Bleeding disorder (any congenital bleeding diathesis)
- Liver dysfunction with end stage liver disease as determined by the treating investigator
- Presence of renal vein thrombus
- End stage renal disease (eGFR < 15 using Cockcroft-gault formula or receiving renal replacement therapy (i.e. dialysis))
- Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 2 weeks after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sutureless, clampless partial nephrectomyAll subjects will undergo a clampless, sutureless robotic partial nephrectomy. | Procedure or surgery | Clampless, sutureless robotic partial nephrectomy |
Primary outcome
Positive margin rate
Time frame: 2-3 weeks post-surgery
Determine the positive margin rate, as measured on the pathology report 2-3 weeks post-surgery.
Transfusion rate
Time frame: 4 weeks post-surgery
Determine the transfusion rate, as measured approximately 4 weeks post-surgery via review of patient medical records.
5 secondary outcomes
Renal dysfunction (1 day post-surgery)
Time frame: 1 day post-surgery
Renal dysfunction (2-3 weeks post-surgery)
Time frame: 2-3 weeks post-surgery
Renal dysfunction (6 months post-surgery)
Time frame: 6 months post-surgery
Estimated blood loss
Time frame: at time of partial nephrectomy
Need for ischemia
Time frame: at time of partial nephrectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crispen, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sutureless, clampless partial nephrectomy in people with Renal Cell Carcinoma (RCC), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive margin rate (time frame: 2-3 weeks post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.