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Laparoscopic Measuring Device Study

Laparoscopic Measuring Device Usability Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03234855
Acronym
LMD-1
Enrollment
50
Registered
2017-07-31
Start date
2017-08-15
Completion date
2017-12-31
Last updated
2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physician Feedback

Brief summary

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.

Interventions

DEVICELMD

Physician uses LMD to measure defect during procedure.

Sponsors

Boehringer Labs LLC
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult patients with hernia defect that requires laparoscopic measurement

Exclusion criteria

* Minors

Design outcomes

Primary

MeasureTime frameDescription
Physician Feedback6 monthsPhysician forms opinion on usefulness and design of LMD

Countries

United States

Contacts

Primary ContactAllen A Orr, BS
aorr@boehringerlabs.com484-931-2314
Backup ContactKevin Klocek
kklocek@boehringerlabs.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026