Cholelithiasis Clinical Trial
Official title:
Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00530998 -
Minimally Invasive Surgery: Using Natural Orfices
|
||
Completed |
NCT00616616 -
Single Incision Laparoscopy
|
N/A | |
Recruiting |
NCT00416234 -
Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis
|
N/A | |
Recruiting |
NCT05975385 -
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
|
N/A | |
Recruiting |
NCT06038201 -
Cholecystectomy vs EUS-guided GBD With Stone Removal
|
N/A | |
Not yet recruiting |
NCT03981315 -
Bile Composition in Healthy and Gallstones Patients
|
||
Completed |
NCT01824186 -
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
|
N/A | |
Completed |
NCT00606762 -
Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy
|
N/A | |
Completed |
NCT00971750 -
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
|
N/A | |
Active, not recruiting |
NCT04279223 -
Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia?
|
N/A | |
Terminated |
NCT01708109 -
Optimal Handling of Common Bile Duct Calculus, a Prospective Study
|
N/A | |
Completed |
NCT01881399 -
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
|
N/A | |
Withdrawn |
NCT01146184 -
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
|
N/A | |
Terminated |
NCT00910325 -
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
|
Phase 1/Phase 2 | |
Completed |
NCT04672902 -
Treatment of Mirizzi Syndrome
|
||
Completed |
NCT03180229 -
Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
|
Phase 4 | |
Completed |
NCT02375529 -
A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
|
N/A | |
Not yet recruiting |
NCT01339325 -
Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE
|
Phase 4 | |
Terminated |
NCT00486655 -
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
|
N/A | |
Completed |
NCT00131131 -
Epidemiology of Gallbladder Sludge and Stones in Pregnancy
|
N/A |