Kidney CalculiNCT00360477
FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy
A study testing Floseal, Cope Loop and Fascial Stitch in people with Kidney Calculi, run by University of California, Irvine at 1 site in United States.
Trial summary
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Floseal, Cope Loop and Fascial Stitch
- 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
- Jun 2004to Jan 2015
- 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
- The patient has kidney stones that require treatment (tx) with percutaneous stone removal
- 18 years of age or over
Who cannot join
- Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
- Patient taking coumadin
- Pre-existing percutaneous nephrostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center-Department of Urology
Orange, California, 92868
About this study
Official title: Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.
- Conditions
- Kidney Calculi
- Being tested
- Floseal, Cope Loop, Fascial Stitch
- Keywords
- Kidney stone removal surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlosealProcedure or surgery
Bioglue that seals the kidney
Cope LoopProcedure or surgery
Nephrostomy tube for fluid drainage from the kidney
Fascial StitchProcedure or surgery
Stitch that closes the kidney
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Floseal Receives: Procedure: Floseal |
| 2 | Active comparator | Cope-Loop/Nephrostomy Tube Receives: Procedure: Cope Loop |
| 3 | Active comparator | Fascial Stitch Receives: Procedure: Fascial Stitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine which method of treatment causes the least pain to the patient.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startJun 2004
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Landman, University of California, Irvine
- Investigators
- Michael K Louie, MD, Principal investigator, UC Irvine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360477
- Sponsor's protocol ID
- 2004-3515
- Status last verified
- Dec 2016
- First submitted
- 3 Aug 2006
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy
- ClinicalTrials.gov ID
- NCT00360477
- Acronym / sponsor ID
- 2004-3515
- Conditions
- Kidney Calculi
- Keywords
- Kidney stone removal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Aug 2006 (estimated)
- 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.
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: FlosealFloseal |
| 2 | Active comparator | Procedure: Cope LoopCope-Loop/Nephrostomy Tube |
| 3 | Active comparator | Procedure: Fascial StitchFascial Stitch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has kidney stones that require treatment (tx) with percutaneous stone removal
- 18 years of age or over
Key exclusion criteria (3 listed)
- Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
- Patient taking coumadin
- Pre-existing percutaneous nephrostomy
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 |
|---|---|---|
| FlosealBioglue that seals the kidney | Procedure or surgery | 1 |
| Cope LoopNephrostomy tube for fluid drainage from the kidney | Procedure or surgery | 2 |
| Fascial StitchStitch that closes the kidney | Procedure or surgery | 3 |
Primary outcome
To determine which method of treatment causes the least pain to the patient.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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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.
Michael K Louie, MD principal investigator
UC Irvine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floseal, Cope Loop and Fascial Stitch in people with Kidney Calculi, run by University of California, Irvine 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine which method of treatment causes the least pain to the patient. (time frame: one month). 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 13 Dec 2016.