NCT00859170

Brief Summary

The objectives of this post-market evaluation are

  1. 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 8, 2010

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

March 5, 2009

Last Update Submit

January 6, 2010

Conditions

Kidney Stones

Keywords

kidney stonesureterlaser lithotripsy

Outcome Measures

Primary Outcomes (1)

  • Incidence of retropulsion or migration of the stone or fragments

    Two months

Secondary Outcomes (4)

  • Elapsed times for placing the safety guidewire

    Two months

  • Fragmenting the stone into pieces no larger than 1 mm in size

    Two months

  • Removing the fragments from the ureter

    Two months

  • Procedure time

    Two months

Study Arms (2)

Accordion use

EXPERIMENTAL

Use of an Accordion device during the lithotripsy.

Device: Accordion device

Control Group

NO INTERVENTION

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

Interventions

Accordion deviceDEVICE

an antiretropulsion device

Also known as: Accordion Stone Management Device PA1205-06-10
Accordion use

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente Bellflower Hospital

Downey, California, 90706, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

USMD Hospital

Arlington, Texas, 76017, United States

Location

Related Publications (4)

  • 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.

    PMID: 18355139RESULT

  • 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.

    PMID: 18186678RESULT

  • 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.

    PMID: 16132755RESULT

  • 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.

    PMID: 15659920RESULT

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas T Lawson, PhD

    Percutaneous Systems, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 10, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

January 8, 2010

Record last verified: 2010-01

Locations

US(3)