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

NCT01982708 | Completed

• 1 other identifier: 13-744FM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Evaluation

Outcome Measures

Primary Outcomes (1)

• Hardness of the abdominal wall

  At intial presentation with abdominal pain

Secondary Outcomes (1)

• temperature of the abdominal wall

  At initial presentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Sparrow Hospital

Lansing, Michigan, 48901, United States

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Robert Osmer, M.D.

  MichiaganSU

  PRINCIPAL INVESTIGATOR

• Marc Basson, M.D., PhD, MBA

  Michigan State University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSU Surgeon

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

US (1)