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Lithotripsy for the Treatment of Gallstones

NCT ID: NCT00042549

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

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The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.

Detailed Description

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This study is a randomized, single-masked controlled trial in which the combination therapy of lithotripsy and the bile acid drug Actigall is compared to monotherapy with only Actigall. The primary objectives are, 1) To determine whether the use of the Medstone STS Lithotripter system in combination with the orally administered drug Actigall is more effective (as measured by percentages of stone free patients 6 months after randomization) in reducing single non-calcified radiolucent gallstones (from 4 to 20mm in diameter) than use of Actigall alone, and 2) To demonstrate that use of the Medstone lithotripsy system is safe (as measured by incidence of adverse events) for the intended purpose, when operated according to its labeling.

Conditions

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Cholelithiasis

Keywords

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Gallstones Gallstone Biliary stones Gallbladder stones Gallbladder Lithotripsy Cholelithiasis ESWL Shock wave Shock waves shockwaves shockwave

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Extracorporeal Shock Wave Lithotripsy

Intervention Type DEVICE

ursodiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of biliary pain
* Evidence of a single noncalcified, radiolucent gallstone between 4 and 20 mm (inclusive) diameter
* HIDA scan demonstrating patency of cystic bile duct
* No cardiac pacemaker
* No allergy to radioopaque dye, iodine, bile acids
* No spontaneous or iatrogenic bleeding disorder
* No current or prior bile duct obstruction, cholangitis, pancreatitis, or cholecystitis
* Not pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medstone International

INDUSTRY

Sponsor Role lead

Principal Investigators

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Atilla Ertan, M.D.

Role: STUDY_DIRECTOR

The Methodist Hospital Research Institute

Locations

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The Methodist Hospital

Houston, Texas, United States

Site Status

Virgina Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Ertan A. Treatment of gallstones by extracorporeal shock wave lithotripsy. Am J Gastroenterol. 2002 Apr;97(4):831-2. doi: 10.1111/j.1572-0241.2002.05738.x. No abstract available.

Reference Type BACKGROUND
PMID: 12003415 (View on PubMed)

Ertan A, Hernandez RE, Campeau RJ, Geshner JR, Litwin MS. Extracorporeal shock-wave lithotripsy and ursodiol versus ursodiol alone in the treatment of gallstones. Gastroenterology. 1992 Jul;103(1):311-6. doi: 10.1016/0016-5085(92)91128-q.

Reference Type BACKGROUND
PMID: 1612339 (View on PubMed)

Vanderpool D, Jones RC, O'Leary JP, Hamilton JK. Biliary lithotripsy. Am J Surg. 1989 Sep;158(3):194-7. doi: 10.1016/0002-9610(89)90251-1.

Reference Type BACKGROUND
PMID: 2672841 (View on PubMed)

Sackmann M, Pauletzki J, Sauerbruch T, Holl J, Schelling G, Paumgartner G. The Munich Gallbladder Lithotripsy Study. Results of the first 5 years with 711 patients. Ann Intern Med. 1991 Feb 15;114(4):290-6. doi: 10.7326/0003-4819-114-4-290.

Reference Type BACKGROUND
PMID: 1987875 (View on PubMed)

Pelletier G, Raymond JM, Capdeville R, Mosnier H, Caroli-Bosc FX. Gallstone recurrence after successful lithotripsy. J Hepatol. 1995 Oct;23(4):420-3. doi: 10.1016/0168-8278(95)80200-2.

Reference Type BACKGROUND
PMID: 8655959 (View on PubMed)

Related Links

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http://patients.uptodate.com/frames.asp?page=tocmain.asp

UpToDate is a practical clinical information service (always current). It is written by a recognized faculty of experts who each address a specific clinical issue. They synthesize the latest evidence and best practices.

Other Identifiers

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GS-PA-001

Identifier Type: -

Identifier Source: org_study_id