Lithotripsy for the Treatment of Gallstones

NCT00042549 | Terminated Phase 4

• 1 other identifier: GS-PA-001
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cholelithiasis

Keywords

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

Interventions

Extracorporeal Shock Wave Lithotripsy DEVICE

ursodiol DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medstone International: lead

Study Sites (2)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Virgina Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

• 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.

  PMID: 12003415 BACKGROUND

• 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.

  PMID: 1612339 BACKGROUND

• 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.

  PMID: 2672841 BACKGROUND

• 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.

  PMID: 1987875 BACKGROUND

• 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.

  PMID: 8655959 BACKGROUND

Related Links

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MeSH Terms

Conditions

Cholelithiasis; Gallstones; Cholecystolithiasis

Interventions

Lithotripsy; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Atilla Ertan, M.D.

  The Methodist Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2002
• First Posted: August 5, 2002
• Study Start: May 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2003-06

Locations

US (2)