Electrohydraulic Versus Laser Lithotripsy for Treatment o... | NCT01571271

Studies
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones

NCT01571271

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Mar 30, 2017Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Gall Stones

Interventions

Laser Lithotripsy
Electrohydraulic Lithotripsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Apr 3, 2012

First Posted Date

Apr 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2017

Last Update Posted Date

Mar 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.

Detailed Description

Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electrohydraulic lithotripsy	Experimental	Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method	Procedure: Electrohydraulic Lithotripsy
Laser Lithotripsy	Experimental	Laser Lithotripsy: Lithotripsy will be performed using laser method	Procedure: Laser Lithotripsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Lithotripsy	Procedure	Laser Lithotripsy	Laser Lithotripsy	Lithotripsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time	Identify which technique takes less time to completion.	Procudre duration

Secondary Outcomes

Measure	Description	Time Frame
Number of shocks	Comparsion between procudures of the number of shocks to fragment stones	Procedure duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
Adults able to provide informed consent

Exclusion Criteria:

Pregnancy or lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mansour A. Parsi, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones
D041761	Cholecystolithiasis

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D005705	Gallbladder Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017602	Lithotripsy, Laser
D008096	Lithotripsy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided