NOTES-Assisted Laparoscopic Cholecystectomy Surgery

This study has been terminated.

(Change of Focus for the company)

Sponsor:

Information provided by:

USGI Medical

ClinicalTrials.gov Identifier:

NCT00486655

First received: June 12, 2007

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2007

Last Updated Date

August 7, 2012

Start Date ^ICMJE

May 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Quality of Life [ Time Frame: 2 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00486655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of complications [ Time Frame: 2 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Official Title ^ICMJE

Assisted Laparoscopic Cholecystectomy Surgery

Brief Summary

This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Detailed Description

A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cholelithiasis
Cholecystitis

Intervention ^ICMJE

Procedure: NOTES-Assisted Cholecystectomy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ability to undergo general anesthesia
Age >= 18 yrs. of age and <= 85 yrs. of age
Ability to give informed consent

Exclusion Criteria:

Acute cholecystitis
BMI >= 40
Contraindicated for EGD
Presence of common duct stones
Presence of esophageal stricture
Altered gastric anatomy

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00486655

Other Study ID Numbers ^ICMJE

LS0701

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

USGI Medical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lee Swanstrom, MD

Oregon Clinic

Information Provided By

USGI Medical

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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