NCT00889928

Brief Summary

The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 24, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

1.6 years

First QC Date

April 28, 2009

Results QC Date

November 1, 2011

Last Update Submit

November 1, 2011

Conditions

Gallbladder Disease

Keywords

gallbladder diseasecholecystectomygallbladder disease indicated for cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Procedure Completion

    Completion of procedure - transvaginal removal of the gallbladder

    Day of Surgery

Study Arms (1)

cholecystectomy

EXPERIMENTAL

transvaginal cholecystectomy

Device: NOTES GEN 1 Toolbox

Interventions

NOTES GEN 1 ToolboxDEVICE

* Articulating Hook Knife * Articulating Snare * Articulating Needle Knife * Articulating Graspers * Articulating Biopsy Forceps * Steerable Flex Trocar with Rotary Access Needle * Flexible Bipolar Hemostasis Forceps * Flexible Maryland Dissector

cholecystectomy

Eligibility Criteria

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

You may qualify if:

  • Women will be enrolled in this study who:
  • Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
  • At least 18 years of age;
  • Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
  • ASA Classification I or II (Appendix II);
  • Have a negative serum pregnancy test (for women of childbearing potential); and
  • Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.

You may not qualify if:

  • Subjects will be excluded from the study for any of the following:
  • BMI \> 35;
  • Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
  • Suspicion of gallbladder cancer, tumor, polyps, or mass;
  • Acute cholecystitis or acute pancreatitis;
  • Presence of common bile duct stones;
  • History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test);
  • Pelvic Inflammatory Disease;
  • Evidence of abdominal abscess or mass;
  • Diffuse peritonitis;
  • Clinical diagnosis of sepsis;
  • History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;
  • History of peritoneal or vaginal trauma;
  • Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
  • Planned concurrent surgical procedure;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Limitations and Caveats

No significant limitations. Small sample size limits inference to a larger population, however it did allow to assess whether the procedure was feasible.

Results Point of Contact

Title
Sheryl Helsinger
Organization
Ethicon Endo Surgery, Inc
SHelsing@its.jnj.com
513-337-3079

Study Officials

  • Eric Hungness, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2010

Study Completion

August 1, 2011

Last Updated

November 24, 2011

Results First Posted

November 24, 2011

Record last verified: 2011-11

Locations

US(1)