protocolSection identificationModule nctId: NCT06296953, orgStudyIdInfo id: PeriSaFe01, secondaryIdInfos id: CIV-23-11-044875, type: OTHER, domain: Swedish Medical Product Agency, briefTitle: Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis, acronym: PeriSaFe01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: STB INN AB, class: INDUSTRY, collaborators name: Scandinavian CRO, collaborators name: Region Halland, descriptionModule briefSummary: 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, conditionsModule conditions: Appendicitis Acute, conditions: Appendicitis, conditions: Abdominal Pain, conditions: Peritonitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PERIsign examination, outcomesModule primaryOutcomes measure: Proportion of subjects experiencing any adverse events during the examination, primaryOutcomes measure: Proportion of device deficiencies during the evaluation, secondaryOutcomes measure: To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system, secondaryOutcomes measure: Proportion of examinations of the PERIsign system that its performed without usability issues., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hallands Sjukhus Halmstad, status: RECRUITING, city: Halmstad, country: Sweden, contacts name: Cleas Hjalmarsson, Ass. Prof., role: CONTACT, contacts name: Åsa Anveden, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 56.67446, lon: 12.85676, locations facility: Hallands Sjukhus Varberg, status: RECRUITING, city: Varberg, country: Sweden, contacts name: Claes Hjalmarsson, ass. Prof, role: CONTACT, contacts name: Stefan Lindskog, ass. prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.10557, lon: 12.25078, hasResults: False