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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00910325
Other study ID # 2008p001938
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received May 27, 2009
Last updated October 29, 2012
Start date November 2008
Est. completion date August 2012

Study information

Verified date October 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 26 Years to 64 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic-assisted transvaginal cholecystectomy
Trans-vaginal Cholecystectomy with Laparoscopic Assistance

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The safety and efficacy of the procedure one year Yes
Secondary Post-operative pain one year No
Secondary Time to return to work one year No
Secondary Time to return to daily activities one year No
See also
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Recruiting NCT05975385 - Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy N/A
Recruiting NCT06038201 - Cholecystectomy vs EUS-guided GBD With Stone Removal N/A
Not yet recruiting NCT03981315 - Bile Composition in Healthy and Gallstones Patients
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Completed NCT00606762 - Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy N/A
Completed NCT00971750 - Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients N/A
Active, not recruiting NCT04279223 - Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia? N/A
Terminated NCT01708109 - Optimal Handling of Common Bile Duct Calculus, a Prospective Study N/A
Completed NCT01881399 - Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy N/A
Withdrawn NCT01146184 - Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) N/A
Completed NCT04672902 - Treatment of Mirizzi Syndrome
Completed NCT03180229 - Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy Phase 4
Not yet recruiting NCT01339325 - Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE Phase 4
Completed NCT02375529 - A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy N/A
Terminated NCT00486655 - NOTES-Assisted Laparoscopic Cholecystectomy Surgery N/A
Completed NCT00131131 - Epidemiology of Gallbladder Sludge and Stones in Pregnancy N/A
Terminated NCT00042549 - Lithotripsy for the Treatment of Gallstones Phase 4