Active Retrieval of Insignificant Fragments During Ureteroscopy

This study is currently recruiting participants.

Verified by The Chaim Sheba Medical Center, March 2008

Sponsored by:	The Chaim Sheba Medical Center
Information provided by:	The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00637650

Purpose

To study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those were small, insignificant fragments were left for spontaneous passage.

Condition	Intervention
Urinary Stones	Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Endoscopic Ureterolithotripsy With or Without Intention to Retrieve Clinically Insignificant Residual Fragments: A Prospective Randomized Trial

Further study details as provided by The Chaim Sheba Medical Center:

Primary Outcome Measures:

need for re-intervention [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hospital Admissions, Visit to ER, need for pain killers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Study Start Date:

December 2006

Arms	Assigned Interventions
B	Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment
A: Experimental Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved	Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with ureteral stones suitable for endoscopic treatment

Exclusion Criteria:

Placement of end procedure double j stent
Any anatomical condition that impairs normal ureteral peristaltism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637650

Contacts

Contact: Oscar Schatloff, MD

oscar.schatloff@gmail.com

Locations

Israel, Ramat Gan
The Chaim Sheba Medical Center	Recruiting
Tel Hashomer, Ramat Gan, Israel, 52621
Contact: Oscar Schatloff, MD oscar.schatloff@gmail.com
Principal Investigator: Oscar Schatloff, MD

Sponsors and Collaborators

The Chaim Sheba Medical Center

More Information

Study ID Numbers:	4638
Study First Received:	March 12, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00637650
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Calculi

ClinicalTrials.gov processed this record on January 16, 2009