Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Stopped early · Phase 1/Phase 2

Conditions studied: Cholelithiasis

In brief

To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.

Key facts

Study ID

NCT00910325

Run by

Massachusetts General Hospital

People needed

3

Starts

2008-11-01

Expected to finish

2012-08-01

Last updated by the study team

2012-10-30

Who can join

Age: 26 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females who are postmenopausal or who no longer wish to bear children
• Females >25 years old and <65 years old
• Diagnosis of biliary disease requiring cholecystectomy
• American Society of Anesthesiology (ASA) Class I or II
• Females who are able to understand and willing to sign an informed consent document

You may not qualify if…

• Pregnancy
• BMI >= 30
• Patients who are still interested in childbearing
• Patients taking immunosuppressive medications or who are immunocompromised
• Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
• Patients with suspicion of gallbladder cancer
• Patients with history of previous open abdominal surgery
• Patients with untreated common bile duct stones

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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