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OpenTrials
Completed

NCT Number: NCT01476748

Intraoperative Trocar Slippage Study

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.

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Key information

Conditions

Trocar Slippage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

LaproStop

Device

One of the subject's trocars will be randomized to be used with a LaproStop device.

Primary outcomes

  1. 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 outcomes

  1. Trocar Slippages Without LaproStop

    Time frame: During the hysterectomy procedure, up to 2 hours and 32 minutes

    Number of participants with slippages with LaproStop

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.