Status:
TERMINATED
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Cholelithiasis
Eligibility:
FEMALE
26-64 years
Phase:
PHASE1
PHASE2
Brief Summary
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 insti...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00910325
Start Date
November 1 2008
End Date
August 1 2012
Last Update
October 30 2012
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114