Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
Status: Not yet recruiting

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

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria for healthy volunteers  For enrolment in the investigation, healthy volunteers must fulfil all the following criteria:  Subject is 18-70 years of age The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all assessments 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:  Patient is 18-70 years of age The patient reports having understood and has signed the ICF and is willing to comply with all assessments The patient is admitted to the hospital with suspected appendicitis and scheduled for emergency surgery within 24 hours. Patient is deemed clinically stable, as judged by the Investigator 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:  BMI >30 Presence of any known pathological diseases in the abdomen Subject who previously underwent abdominal surgery Subject with spinal cord injury Subject with pacemaker Pregnancy at the time of enrollment, as confirmed by either knowledge or a urine test The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason 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:  BMI >30 Patient who previously underwent abdominal surgery The patient is currently undergoing immunosuppressive therapy, including systemic corticosteroid treatment for two weeks prior to enrollment Patient with spinal cord injury Patient with pacemaker Known abdominal ventral hernia Known abdominal rectus muscle diastasis Retrocecal appendix according to radiology 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 The patient must not be pregnant at the time of enrollment, as confirmed by either prior knowledge or a urine test The patient has a cognitive incapacity or language barrier precluding adequate understanding or cooperation The patient is considered by the Investigator to be unsuitable to participate in the investigation for any other reason The PERIsign examination is deemed to interfere with the standard of care Subject already enrolled (within 30 days prior to enrolment) in another investigational drug/s or device/s clinical study - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult