Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis

Summary

This will be an explorative, proof-of-principle, open, multi-center investigation.

The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals and subjects with involuntary muscle defense as a sign of peritonitis by utilizing PERIsign data. The investigation will include a total of 20 subjects admitted to hospital for suspected appendicitis and planned for emergency surgery and 20 healthy volunteers. Both male and female subjects aged 18-70 years will be enrolled.

All subjects will undergo PERIsign examinations. Subjects with suspected appendicitis will undergo 1-2 PERIsign examinations before their planned appendectomy surgery. For the healthy volunteers, there is only 1 PERIsign examination. During each examination, 4 PERIsign curves will be obtained, one from each quadrant of the abdomen. The attending physician will interpret the appearance of the PERIsign curves of all subjects, including those from the healthy volunteers. The duration of the PERIsign examination will be documented, and usability data will be gathered, including the need for sensor adjustments, subject perception of the examination, and any discomfort experienced. In addition, blinded physicians will evaluate all subjects' PERIsign curves and determine whether each subject has involuntary muscle defense as a sign of peritonitis. These blinded physicians will have access to all 4 PERIsign curves obtained during each examination, while other data will not be disclosed to them.

Safety will be evaluated through analysis of reported adverse events and device deficiencies

Conditions

• Appendicitis Acute
• Appendicitis
• Abdominal Pain
• Peritonitis

Interventions

DEVICE

PERIsign examination

Patients will be examined with the new device, PERIsign

Sponsors & Collaborators

• Aurevia

  collaborator INDUSTRY

• Region Halland

  collaborator OTHER

• STB INN AB

  lead INDUSTRY

Principal Investigators

• Stefan Lindskog, ass. Prof · Region Halland

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-15

Primary Completion

2024-08-01

Completion

2024-08-01

Countries

• Sweden

Study Locations