A Prospective Study of a Haptic Device Evaluation of the Acute Abdomen

A Prospective Study of a Haptic Device Evaluation of the Acute Abdomen

Sponsors

Lead Sponsor: Michigan State University

Source Michigan State University
Brief Summary

The study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen. Investigators from the MSU Department of Surgery in Collaboration with MSU Engineering are assessing the ability of a non invasive, optical device that is placed on a patients abdomen (much like an ultrasound transducer) to evaluate a patient with an acute abdominal presentation. Conditions such as appendicitis, cholecystitis, diverticulitis or small bowel obstruction will be examined with the haptic device. Data will be collected by the device and later compared to the abdominal findings recorded from an examination conducted by the principle investigator who is a surgeon. The surgeon will not have acess to data collected by the haptic sensor and therefore it will have no impact on the decision making process in the care of the patient. The impact on the individual patient will require obtaining a consent to participate in the study, a few minutes to place the device gently on the abdomen and collect the sensor data. There is no direct benefit to the patient by participating in the study. The potential for such a study may be to develop the technology to have a device that non-medical staff can use to collect patient data and transmit that data to a healthcare provider at another location.

Overall Status Completed
Start Date December 2013
Completion Date June 2014
Primary Completion Date June 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Hardness of the abdominal wall At intial presentation with abdominal pain
Secondary Outcome
Measure Time Frame
temperature of the abdominal wall At initial presentation
Enrollment 20
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- All patients referred to the MSU Acute Care Surgery service for the evaluation of abdominal pain.

Exclusion Criteria:

- Under 18 years of age

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Sparrow Hospital
Location Countries

United States

Verification Date

June 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Michigan State University

Investigator Full Name: Robert Osmer

Investigator Title: MSU Surgeon

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov