NCT03234855

Laparoscopic Measuring Device Study

Laparoscopic Measuring Device Usability Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Boehringer Labs LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Physician Feedback

Interventions

Type	Name	Description
DEVICE	LMD	Physician uses LMD to measure defect during procedure.

Timeline

• Start date: 2017-08-15
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-07-31
• Last updated: 2017-07-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study