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

Completed

• Conditions: Acute Abdomen

• Registration Number: NCT01982708
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-13
• Study Start: 2013-12
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-11
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hardness of the abdominal wall	At intial presentation with abdominal pain

Secondary Outcome Measures

Name	Time	Method
temperature of the abdominal wall	At initial presentation

Trial Locations

Locations (1)

Sparrow Hospital; 🇺🇸 Lansing, Michigan, United States