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

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.

Study Overview

• Status: Completed
• Conditions: Acute Abdomen

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Lansing, Michigan, United States, 48901
      • Sparrow Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Emergency department and inpatient referrals for general surgery evaluation for acute abdominal presentation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hardness of the abdominal wall	At intial presentation with abdominal pain

Secondary Outcome Measures

Outcome Measure	Time Frame
temperature of the abdominal wall	At initial presentation

Collaborators and Investigators

• Sponsor: Michigan State University
• Investigators: Principal Investigator: Robert Osmer, M.D., MichiaganSU; Study Chair: Marc Basson, M.D., PhD, MBA, Michigan State University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): June 13, 2014
• Last Update Submitted That Met QC Criteria: June 11, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Evaluation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Abdomen, Acute
• Other Study ID Numbers: 13-744FM