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

NCT ID: NCT01982708

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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.

Conditions

Acute Abdomen

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Robert Osmer

MSU Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Osmer, M.D.

Role: PRINCIPAL_INVESTIGATOR

MichiaganSU

Marc Basson, M.D., PhD, MBA

Role: STUDY_CHAIR

Michigan State University

Locations

Sparrow Hospital

Lansing, Michigan, United States

Countries

United States

Other Identifiers

13-744FM

Identifier Type: -

Identifier Source: org_study_id