Kidney StonesNCT00859170
Use of Antiretropulsion Device in Laser Lithotripsy
A study testing Accordion device in people with Kidney Stones, run by Percutaneous Systems, Inc. at 3 sites in United States.
Trial summary
The objectives of this post-market evaluation are 1. to assess the capacity of the procedure to be completed with use of only a semi-rigid ureteroscope, without requiring use of a flexible ureteroscope 2. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Accordion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2009to Aug 2009
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solitary ureteral stone in the distal or medial ureter, 10 mm in diameter or less, as demonstrated by preoperative CT or IVP imaging and are 18 years of age or older.
Who cannot join
- Patients will be excluded from this study if they have active urinary tract infection, or, if female, pregnant, or has clinical evidence of sepsis, or a single or nonfunctioning kidney, or coagulopathy, or congenital ureteral abnormality, or previous ureteral reimplantation, or presence of any degree of ureteral stricture distal to the stone, as determined before or during the procedure, or inability to sign informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
USMD Hospital
Arlington, Texas, 76017
Kaiser Permanente Bellflower Hospital
Downey, California, 90706
New York University Medical Center
New York, New York, 10016
About this study
Official title: Use of the Accordion Stone Management Device in Laser Lithotripsy
The objectives of this post-market evaluation are
- to assess the capacity of the procedure to be completed with use of only a semi-rigid ureteroscope, without requiring use of a flexible ureteroscope
- to compare the rate of retropulsion and the time required to complete the lithotripsy in patients in which the Accordion device is used in contrast to when such a device is not employed.
Read the detailed description
In North America, ureteroscopic-guided lithotripsy with the holmium:yttrium-aluminum-garnet (Ho:YAG) laser has increased in clinical utility owing to its capacity to fragment stones of all compositions. However, with the application of the light energy, retropulsion of the stone is possible due to the combined effects of fragment ejection, water vaporization, and cavitation bubble expansion then collapse. Reducing the laser energy and using laser fibers with small diameters are options to address such a consequence, but these changes have the potential to reduce the efficacy of the laser treatment.
Movement of stones and stone fragments during laser lithotripsy also can be caused by the application of irrigation during the procedure. Irrigation is necessary in order to maintain clear visualization of the targeted stone during lithotripsy, and yet irrigation flow pressure can push stones away from the laser tip, requiring repositioning of the laser, and, in the presence of hydrodilation of the ureter, cause the stone to float up to the renal pelvis or into the kidney itself. In such a situation the physician may be required to use more specialized instruments, adding to the complexity and cost of the procedure. As a result, physicians monitor irrigation closely and will reduce the flow if retropulsion of the stone or fragments occurs.
Retropulsion of stones and stone fragments during laser lithotripsy has been reported in up to 24% of patients and can cause prolonged operative times due to near-constant repositioning of the laser fiber between firings, and as well as result in additional treatment methods, making available a flexible ureteroscope, with its associated costs, and additional cost associated with an extended procedure.
A novel occluding guidewire, the Accordion Stone Management Device, has been developed that can be advanced up the ureter and past the stone. Once past the stone, an occlusion film is engaged within the lumen of the ureter in order to limit retropulsion of the stone and its fragments, irrespective of the laser energy, flow rate of irrigation, or dilation of the ureter. Reduction of stone fragment movement has the potential to reduce operative time and increase stone-free rates within this population.
- Conditions
- Kidney Stones
- Being tested
- Accordion device
- Keywords
- kidney stones, ureter, laser lithotripsy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accordion deviceDevice
Also called Accordion Stone Management Device PA1205-06-10
an antiretropulsion device
| Study group | Role | What they receive |
|---|---|---|
| Accordion use | Experimental | Use of an Accordion device during the lithotripsy. Receives: Device: Accordion device |
| Control Group | No intervention | Patients who will not have an Accordion device used during lithotripsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of retropulsion or migration of the stone or fragments
Measured: Two months
Secondary outcomes (4)
Elapsed times for placing the safety guidewire
Measured: Two months
Fragmenting the stone into pieces no larger than 1 mm in size
Measured: Two months
Removing the fragments from the ureter
Measured: Two months
Procedure time
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009 (estimated)
- Study completionAug 2009 (estimated)
Why it stopped: Change in priorities occurred
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Percutaneous Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas T Lawson, PhD, Study director, Percutaneous Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859170
- Sponsor's protocol ID
- 08-001
- Status last verified
- Jan 2010
- First submitted
- 5 Mar 2009
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Manohar T, Ganpule A, Desai M. Comparative evaluation of Swiss LithoClast 2 and holmium:YAG laser lithotripsy for impacted upper-ureteral stones. J Endourol. 2008 Mar;22(3):443-6. doi: 10.1089/end.2007.0288.
PubMed 18355139Bapat SS, Pai KV, Purnapatre SS, Yadav PB, Padye AS. Comparison of holmium laser and pneumatic lithotripsy in managing upper-ureteral stones. J Endourol. 2007 Dec;21(12):1425-7. doi: 10.1089/end.2006.0350.
PubMed 18186678Ilker Y, Ozgur A, Yazici C. Treatment of ureteral stones using Holmium:YAG laser. Int Urol Nephrol. 2005;37(1):31-4. doi: 10.1007/s11255-004-6084-3.
PubMed 16132755Maislos SD, Volpe M, Albert PS, Raboy A. Efficacy of the Stone Cone for treatment of proximal ureteral stones. J Endourol. 2004 Nov;18(9):862-4. doi: 10.1089/end.2004.18.862.
PubMed 15659920
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Accordion Stone Management Device in Laser Lithotripsy
- ClinicalTrials.gov ID
- NCT00859170
- Acronym / sponsor ID
- 08-001
- Conditions
- Kidney Stones
- Keywords
- kidney stones, ureter, laser lithotripsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in priorities occurred
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Percutaneous Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 10 Mar 2009 (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 objectives of this post-market evaluation are
- to assess the capacity of the procedure to be completed with use of only a semi-rigid ureteroscope, without requiring use of a flexible ureteroscope
- to compare the rate of retropulsion and the time required to complete the lithotripsy in patients in which the Accordion device is used in contrast to when such a device is not employed.
Detailed description
In North America, ureteroscopic-guided lithotripsy with the holmium:yttrium-aluminum-garnet (Ho:YAG) laser has increased in clinical utility owing to its capacity to fragment stones of all compositions. However, with the application of the light energy, retropulsion of the stone is possible due to the combined effects of fragment ejection, water vaporization, and cavitation bubble expansion then collapse. Reducing the laser energy and using laser fibers with small diameters are options to address such a consequence, but these changes have the potential to reduce the efficacy of the laser treatment.
Movement of stones and stone fragments during laser lithotripsy also can be caused by the application of irrigation during the procedure. Irrigation is necessary in order to maintain clear visualization of the targeted stone during lithotripsy, and yet irrigation flow pressure can push stones away from the laser tip, requiring repositioning of the laser, and, in the presence of hydrodilation of the ureter, cause the stone to float up to the renal pelvis or into the kidney itself. In such a situation the physician may be required to use more specialized instruments, adding to the complexity and cost of the procedure. As a result, physicians monitor irrigation closely and will reduce the flow if retropulsion of the stone or fragments occurs.
Retropulsion of stones and stone fragments during laser lithotripsy has been reported in up to 24% of patients and can cause prolonged operative times due to near-constant repositioning of the laser fiber between firings, and as well as result in additional treatment methods, making available a flexible ureteroscope, with its associated costs, and additional cost associated with an extended procedure.
A novel occluding guidewire, the Accordion Stone Management Device, has been developed that can be advanced up the ureter and past the stone. Once past the stone, an occlusion film is engaged within the lumen of the ureter in order to limit retropulsion of the stone and its fragments, irrespective of the laser energy, flow rate of irrigation, or dilation of the ureter. Reduction of stone fragment movement has the potential to reduce operative time and increase stone-free rates within this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accordion use | Experimental | Device: Accordion deviceUse of an Accordion device during the lithotripsy. |
| Control Group | No intervention | –Patients who will not have an Accordion device used during lithotripsy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Solitary ureteral stone in the distal or medial ureter, 10 mm in diameter or less, as demonstrated by preoperative CT or IVP imaging and are 18 years of age or older.
Key exclusion criteria (1 listed)
- Patients will be excluded from this study if they have active urinary tract infection, or, if female, pregnant, or has clinical evidence of sepsis, or a single or nonfunctioning kidney, or coagulopathy, or congenital ureteral abnormality, or previous ureteral reimplantation, or presence of any degree of ureteral stricture distal to the stone, as determined before or during the procedure, or inability to sign informed consent.
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 |
|---|---|---|
| Accordion deviceAlso: Accordion Stone Management Device PA1205-06-10an antiretropulsion device | Device | Accordion use |
Primary outcome
Incidence of retropulsion or migration of the stone or fragments
Time frame: Two months
4 secondary outcomes
Elapsed times for placing the safety guidewire
Time frame: Two months
Fragmenting the stone into pieces no larger than 1 mm in size
Time frame: Two months
Removing the fragments from the ureter
Time frame: Two months
Procedure time
Time frame: Two months
Results and safety
The study was stopped early (reason given: Change in priorities occurred). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
- Results publication: PubMed 18355139Manohar T, Ganpule A, Desai M. Comparative evaluation of Swiss LithoClast 2 and holmium:YAG laser lithotripsy for impacted upper-ureteral stones. J Endourol. 2008 Mar;22(3):443-6. doi: 10.1089/end.2007.0288.
- Results publication: PubMed 18186678Bapat SS, Pai KV, Purnapatre SS, Yadav PB, Padye AS. Comparison of holmium laser and pneumatic lithotripsy in managing upper-ureteral stones. J Endourol. 2007 Dec;21(12):1425-7. doi: 10.1089/end.2006.0350.
- Results publication: PubMed 16132755Ilker Y, Ozgur A, Yazici C. Treatment of ureteral stones using Holmium:YAG laser. Int Urol Nephrol. 2005;37(1):31-4. doi: 10.1007/s11255-004-6084-3.
- Results publication: PubMed 15659920Maislos SD, Volpe M, Albert PS, Raboy A. Efficacy of the Stone Cone for treatment of proximal ureteral stones. J Endourol. 2004 Nov;18(9):862-4. doi: 10.1089/end.2004.18.862.
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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.
Thomas T Lawson, PhD study director
Percutaneous Systems, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accordion device in people with Kidney Stones, run by Percutaneous Systems, Inc. at 3 sites 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Change in priorities occurred). 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?
Incidence of retropulsion or migration of the stone or fragments (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00859170, which also lists 4 linked publications.
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 8 Jan 2010.