Use of Antiretropulsion Device in Laser Lithotripsy

NCT ID: NCT00859170

Last Updated: 2010-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-08-31

Brief 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. 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.

Conditions

Kidney Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Accordion use

Use of an Accordion device during the lithotripsy.

Group Type: EXPERIMENTAL

Accordion device

Intervention Type: DEVICE

an antiretropulsion device

Control Group

Patients who will not have an Accordion device used during lithotripsy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Accordion device

an antiretropulsion device

Intervention Type: DEVICE

Other Intervention Names

Accordion Stone Management Device PA1205-06-10

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Percutaneous Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Percutaneous Systems, Inc.

Principal Investigators

Thomas T Lawson, PhD

Role: STUDY_DIRECTOR

Percutaneous Systems, Inc.

Locations

Kaiser Permanente Bellflower Hospital

Downey, California, United States

New York University Medical Center

New York, New York, United States

USMD Hospital

Arlington, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18355139 (View on PubMed)

Bapat 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.

Reference Type: RESULT

PMID: 18186678 (View on PubMed)

Ilker 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.

Reference Type: RESULT

PMID: 16132755 (View on PubMed)

Maislos 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.

Reference Type: RESULT

PMID: 15659920 (View on PubMed)

Other Identifiers

08-001

Identifier Type: -

Identifier Source: org_study_id