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

Acute Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982708
• Other study ID #: 13-744FM
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: June 11, 2014
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen

Locations

Country	Name	City	State
United States	Sparrow Hospital	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hardness of the abdominal wall		At intial presentation with abdominal pain	No
Secondary	temperature of the abdominal wall		At initial presentation	No