Trocar SlippagePhase 3NCT01476748
Intraoperative Trocar Slippage Study
A Phase 3 study testing LaproStop in people with Trocar Slippage, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trocar Slippage
- What is being tested?
- LaproStop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.
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.
- Conditions
- Trocar Slippage
- Being tested
- LaproStop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaproStopDevice
One of the subject's trocars will be randomized to be used with a LaproStop device.
| Study group | Role | What they receive |
|---|---|---|
| Ethicon Xcel Trocars | Active comparator | Ethicon Xcel trocars will be used in this arm with Laprostop device Receives: Device: LaproStop |
| Covidien Veraport Trocars | Active comparator | Covidien Veraport Trocars will be used in this arm with the Laprostop device Receives: Device: LaproStop |
| Storz Reusable Trocars | Active comparator | Storz Reusable Trocars will be used in this arm with the Laprostop device Receives: Device: LaproStop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trocar Slippages With LaproStop
Number of participants with slippages with LaproStop
Measured: During the hysterectomy procedure, up to 2 hours and 32 minutes
Secondary outcomes (1)
Trocar Slippages Without LaproStop
Number of participants with slippages with LaproStop
Measured: During the hysterectomy procedure, up to 2 hours and 32 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trocar SlippageStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon I. Einarsson, Brigham and Women's Hospital
- Investigators
- Jon I Einarsson, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476748
- Sponsor's protocol ID
- 2011P001825
- Status last verified
- Sep 2014
- First submitted
- 18 Nov 2011
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.
- ClinicalTrials.gov ID
- NCT01476748
- Acronym / sponsor ID
- 2011P001825
- Conditions
- Trocar Slippage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ethicon Xcel Trocars | Active comparator | Device: LaproStopEthicon Xcel trocars will be used in this arm with Laprostop device |
| Covidien Veraport Trocars | Active comparator | Device: LaproStopCovidien Veraport Trocars will be used in this arm with the Laprostop device |
| Storz Reusable Trocars | Active comparator | Device: LaproStopStorz Reusable Trocars will be used in this arm with the Laprostop device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaproStopOne of the subject's trocars will be randomized to be used with a LaproStop device. | Device | Covidien Veraport Trocars, Ethicon Xcel Trocars, Storz Reusable Trocars |
Primary outcome
Trocar Slippages With LaproStop
Time frame: During the hysterectomy procedure, up to 2 hours and 32 minutes
Number of participants with slippages with LaproStop
1 secondary outcome
Trocar Slippages Without LaproStop
Time frame: During the hysterectomy procedure, up to 2 hours and 32 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon I Einarsson, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LaproStop in people with Trocar Slippage, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trocar Slippages With LaproStop (time frame: During the hysterectomy procedure, up to 2 hours and 32 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.