- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00910325
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
October 29, 2012 updated by: David W. Rattner, MD, Massachusetts General Hospital
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The safety and efficacy of the procedure
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post-operative pain
Time Frame: one year
|
one year
|
Time to return to work
Time Frame: one year
|
one year
|
Time to return to daily activities
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David W Rattner, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 27, 2009
First Submitted That Met QC Criteria
May 28, 2009
First Posted (Estimate)
May 29, 2009
Study Record Updates
Last Update Posted (Estimate)
October 30, 2012
Last Update Submitted That Met QC Criteria
October 29, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008p001938
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Laparoscopic-assisted transvaginal cholecystectomy
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University of Texas Southwestern Medical CenterWithdrawnCholelithiasis
-
Yale UniversityCompleted
-
Imperial College LondonCompletedCholecystitis | Biliary ColicUnited Kingdom
-
University of ZurichCompletedCholecystolithiasisSwitzerland
-
The Oregon ClinicNorthwestern UniversityCompletedCholecystitisUnited States
-
Hospital Son LlatzerCompleted
-
Kantonsspital Winterthur KSWUnknownBenign Gallbladder DiseaseSwitzerland
-
University of California, San DiegoCompletedAppendicitis | Gallstones | CholelithiasisUnited States
-
Northwestern UniversityEthicon Endo-SurgeryCompletedEndoscopy | Cholecystectomy, LaparoscopicUnited States
-
Intuitive SurgicalRecruitingLaparoscopic Cholecystectomy | Robotic-assisted CholecystectomyUnited States