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

Inclusion Criteria:

Inclusion criteria for healthy volunteers

For enrolment in the investigation, healthy volunteers must fulfil all the following criteria:

1. Subject is 18-70 years of age
2. The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all assessments
3. The subject should have a sufficient height and physical build to enable the attachment of the PERIsign sensors to their abdomen, as judged by the Investigator Inclusion criteria for the patient group

For enrolment in the investigation, patients must fulfil all the following criteria:

1. Patient is 18-70 years of age
2. The patient reports having understood and has signed the ICF and is willing to comply with all assessments
3. The patient is admitted to the hospital with suspected appendicitis and scheduled for emergency surgery within 24 hours.
4. Patient is deemed clinically stable, as judged by the Investigator
5. The patient should have a sufficient height and physical build to enable the attachment of the PERIsign sensors to their abdomen, as judged by the Investigator

Exclusion Criteria:

Exclusion criteria for healthy volunteers

Healthy volunteers meeting any of the following criteria will not be permitted to enter the investigation:

1. BMI >30
2. Presence of any known pathological diseases in the abdomen
3. Subject who previously underwent abdominal surgery
4. Subject with spinal cord injury
5. Subject with pacemaker
6. Pregnancy at the time of enrollment, as confirmed by either knowledge or a urine test
7. The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
8. The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
9. Subject already enrolled (within 30 days prior to enrolment) in another investigational drug/s or device/s clinical study Exclusion criteria for the patient group

Patients meeting any of the following criteria will not be permitted to enter the investigation:

1. BMI >30
2. Patient who previously underwent abdominal surgery
3. The patient is currently undergoing immunosuppressive therapy, including systemic corticosteroid treatment for two weeks prior to enrollment
4. Patient with spinal cord injury
5. Patient with pacemaker
6. Known abdominal ventral hernia
7. Known abdominal rectus muscle diastasis
8. Retrocecal appendix according to radiology
9. Other known pathological conditions of the abdomen that may interfere with the performance, evaluation and outcome of the clinical evaluation, as determined by the Investigator
10. The patient must not be pregnant at the time of enrollment, as confirmed by either prior knowledge or a urine test
11. The patient has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
12. The patient is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
13. The PERIsign examination is deemed to interfere with the standard of care
14. Subject already enrolled (within 30 days prior to enrolment) in another investigational drug/s or device/s clinical study -