Lithotripsy for the Treatment of Gallstones

13:00 EST 28th November 2014 | BioPortfolio

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Cholelithiasis

Intervention

Extracorporeal Shock Wave Lithotripsy, ursodiol

Location

The Methodist Hospital
Houston
Texas
United States
77030

Status

Terminated

Source

Medstone International

Results (where available)

View Results

Links

Clinical Trials [208 Associated Clinical Trials listed on BioPortfolio]

Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis

Endoscopy is an established method of treatment for painful obstructive calcified pancreatitis. It involves the disintegration of calcifications using extracorporeal shock wave lithotripsy...

Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ?

The purpose of this study is to determine if there is a role of prophylactic therapy with tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse. 150 p...

Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi

Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from ...

Study on 'The Use of Non-Contrast Helical Computerized Tomogram in Predicting Treatment Outcomes of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter'

The purpose of this research is to assess the role of non-contrast helical computerized tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock wave li...

PubMed Articles [2274 Associated PubMed Articles listed on BioPortfolio]

The effect of terpene combination on ureter calculus expulsion after extracorporeal shock wave lithotripsy.

Terpene combination (Rowatinex) is known to help with the expulsion of urinary stones. The aim of this study was to determine how Rowatinex affects the expulsion of remnant stones after shock wave lit...

Extracorporeal shock wave lithotripsy for difficult common bile duct stones: a comparison between 2 different lithotripters in a large cohort of patients.

Extracorporeal shock wave lithotripsy (ESWL) for difficult common bile duct (CBD) stones is a safe and effective treatment strategy allowing for bile duct clearance in approximately 90% of patients wi...

RE: EFFECTIVENESS OF EXTRACORPOREAL SHOCK WAVE THERAPY IN CHRONIC PLANTAR FASCIITIS.

Scrotal hematoma resulting from extracorporeal shock wave lithotripsy for a renal calculus: a sign of retroperitoneal hemorrhage.

We report a rare case of a patient presenting with scrotal hematoma associated with retroperitoneal hemorrhage after extracorporeal shock wave lithotripsy (ESWL). We propose a mechanism for the format...

Why Does Anyone Get Shock Wave Lithotripsy?

Medical and Biotech [MESH] Definitions

The destruction of a calculus of the kidney, ureter, bladder, or gallbladder by physical forces, including crushing with a lithotriptor through a catheter. Focused percutaneous ultrasound and focused hydraulic shock waves may be used without surgery. Lithotripsy does not include the dissolving of stones by acids or litholysis. Lithotripsy by laser is LITHOTRIPSY, LASER.

A family of heat-shock proteins that contain a 70 amino-acid consensus sequence known as the J domain. The J domain of HSP40 heat shock proteins interacts with HSP70 HEAT-SHOCK PROTEINS. HSP40 heat-shock proteins play a role in regulating the ADENOSINE TRIPHOSPHATASES activity of HSP70 heat-shock proteins.

Shock produced as a result of trauma.

A subfamily of small heat-shock proteins that are closely related to ALPHA B-CRYSTALLIN. Hsp20 heat-shock proteins can undergo PHOSPHORYLATION by CYCLIC GMP-DEPENDENT PROTEIN KINASES.

Shock resulting from diminution of cardiac output in heart disease.

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