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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00486655
Other study ID # LS0701
Secondary ID
Status Terminated
Phase N/A
First received June 12, 2007
Last updated August 7, 2012
Start date May 2007
Est. completion date June 2007

Study information

Verified date August 2012
Source USGI Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

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


Intervention

Procedure:
NOTES-Assisted Cholecystectomy


Locations

Country Name City State
United States Oregon Clinic Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
USGI Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life 2 weeks
Secondary Incidence of complications 2 weeks
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