Physician FeedbackLMD-1NCT03234855
Laparoscopic Measuring Device Study
An observational study of Physician Feedback, run by Boehringer Labs LLC at 3 sites in United States.
Trial summary
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Physician Feedback
- What is being tested?
- LMD
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients whose physician has already decided that laparoscopic hernia repair surgery is the best route of treatment for a hernia defect.
Who may be able to join
- Adult patients with hernia defect that requires laparoscopic measurement
Who cannot join
- Minors
Trial locations and contacts
3 sites in 1 country.
Kevin Klocek contact
United States3 sites
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Jennifer Denne, MD, 610-527-1185
Temple University
Philadelphia, Pennsylvania, 19140
Tatyan Clarke, MD, 215-707-2000
University of Pennsylvania
Philadelphia, Pennsylvania, 19140
Ian Soriano, MD, 215-707-8269
David Wernsing, MD, 215-829-8455
About this study
Official title: Laparoscopic Measuring Device Usability Study
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.
Read the detailed description
In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued a recommendation stating that:
"Surgeons should measure and document the size of the hernia defect they are repairing. The total area encompassing all the defects should be measured, and surgeons should be familiar with internal and external measurement techniques for all hernia locations, as well as how to avoid common measurement errors."
An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh. According to the SAGES recommendation:
"Overestimating the defect size will result in the choice of a larger prosthetic size, which may be more difficult to handle and may have more laxity, allowing it to bulge into the defect more than if it was placed taut. The difficulty in prosthetic handling may also lead to errors in fixation, and the prosthetic can more easily sway between fixation points, due to the larger dimensions."
While a smaller mesh size can also be problematic:
"Underestimating the defect size may lead to choosing a prosthetic that is too small, thus increasing the risk of hernia recurrence." In order to aid surgeons in more accurately measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring device. This study aims to obtain feedback from surgeons on the usefulness and design of the device.
- Conditions
- Physician Feedback
- Being tested
- LMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMDDevice
Physician uses LMD to measure defect during procedure.
| Study group | Role | What they receive |
|---|---|---|
| LMD | Physician uses LMD during procedure. Receives: Device: LMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Feedback
Physician forms opinion on usefulness and design of LMD
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start15 Aug 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician FeedbackStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234855
- Sponsor's protocol ID
- LMD-1
- Acronym
- LMD-1
- Status last verified
- Jul 2017
- First submitted
- 27 Jul 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No patient data will be collected
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Measuring Device Usability Study
- ClinicalTrials.gov ID
- NCT03234855
- Acronym / sponsor ID
- LMD-1 / LMD-1
- Conditions
- Physician Feedback
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boehringer Labs LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.
Detailed description
In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued a recommendation stating that:
"Surgeons should measure and document the size of the hernia defect they are repairing. The total area encompassing all the defects should be measured, and surgeons should be familiar with internal and external measurement techniques for all hernia locations, as well as how to avoid common measurement errors."
An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh. According to the SAGES recommendation:
"Overestimating the defect size will result in the choice of a larger prosthetic size, which may be more difficult to handle and may have more laxity, allowing it to bulge into the defect more than if it was placed taut. The difficulty in prosthetic handling may also lead to errors in fixation, and the prosthetic can more easily sway between fixation points, due to the larger dimensions."
While a smaller mesh size can also be problematic:
"Underestimating the defect size may lead to choosing a prosthetic that is too small, thus increasing the risk of hernia recurrence." In order to aid surgeons in more accurately measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring device. This study aims to obtain feedback from surgeons on the usefulness and design of the device.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LMD | – | Device: LMDPhysician uses LMD during procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose physician has already decided that laparoscopic hernia repair surgery is the best route of treatment for a hernia defect.
Key inclusion criteria (1 listed)
- Adult patients with hernia defect that requires laparoscopic measurement
Key exclusion criteria (1 listed)
- Minors
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 |
|---|---|---|
| LMDPhysician uses LMD to measure defect during procedure. | Device | LMD |
Primary outcome
Physician Feedback
Time frame: 6 months
Physician forms opinion on usefulness and design of LMD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Individual participant dataSharing planned: No. No patient data will be collected
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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.
Kevin Klocek contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physician Feedback, run by Boehringer Labs LLC at 3 sites 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 1 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: status not confirmed, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allen A Orr, BS (484-931-2314, aorr@boehringerlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Feedback (time frame: 6 months). 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 31 Jul 2017.