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Intraoperative Trocar Slippage Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476748
First Posted: November 22, 2011
Last Update Posted: September 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital
  Purpose

The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage.

Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.


Condition Intervention Phase
Trocar Slippage Device: LaproStop Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.

Further study details as provided by Jon I. Einarsson, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Trocar Slippages With LaproStop [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ]
    Number of participants with slippages with LaproStop


Secondary Outcome Measures:
  • Trocar Slippages Without LaproStop [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ]
    Number of participants with slippages with LaproStop


Enrollment: 15
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ethicon Xcel Trocars
Ethicon Xcel trocars will be used in this arm with Laprostop device
Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.
Active Comparator: Covidien Veraport Trocars
Covidien Veraport Trocars will be used in this arm with the Laprostop device
Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.
Active Comparator: Storz Reusable Trocars
Storz Reusable Trocars will be used in this arm with the Laprostop device
Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476748


Locations
United States, Massachusetts
Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jon I Einarsson, MD, MPH Brigham and Women's Hospital
  More Information

Responsible Party: Jon I. Einarsson, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01476748     History of Changes
Other Study ID Numbers: 2011P001825
First Submitted: November 18, 2011
First Posted: November 22, 2011
Results First Submitted: August 23, 2013
Results First Posted: August 29, 2014
Last Update Posted: September 17, 2014
Last Verified: September 2014