Electrohydraulic Versus Laser Lithotripsy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01039246
First received: December 23, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

This study compares the efficacy and ease of use of two methods to break up biliary stones. Electrohydraulic lithotripsy uses an electric spark, and the laser system uses light to create shock waves that break up the stones.


Condition Intervention
Gall Stones
Procedure: Electrohydraulic lithotripsy
Procedure: Laser Lithotripsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrohydraulic Versus Laser Lithotripsy for Difficult to Remove Biliary Stones: A Randomized Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Number of sessions required for complete stone removal [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Electrohydraulic lithotripsy Procedure: Electrohydraulic lithotripsy
Fragmentation of biliary stones using elctrohydraulic lithotripsy
Active Comparator: Laser Lithotripsy Procedure: Laser Lithotripsy
Fragmentation of biliary stones using laser lithotripsy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 years and older
  • Biliary stone(s) not amenable to removal by conventional means
  • Patients able to give informed consent

Exclusion Criteria:

  • Pregnant women
  • Lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039246

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mansour A Parsi, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01039246     History of Changes
Other Study ID Numbers: CCF 09-168
Study First Received: December 23, 2009
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
biliary stones

ClinicalTrials.gov processed this record on October 30, 2014