NCT00486655

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

First QC Date

June 12, 2007

Last Update Submit

August 7, 2012

Conditions

CholelithiasisCholecystitis

Keywords

CholecystectomyNOTESTransgastric

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    2 weeks

Secondary Outcomes (1)

  • Incidence of complications

    2 weeks

Interventions

NOTES-Assisted CholecystectomyPROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Clinic

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

CholelithiasisCholecystitis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Lee Swanstrom, MD

    Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 14, 2007

Study Start

May 1, 2007

Study Completion

June 1, 2007

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

US(1)