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

NCT06296953 | Completed DMC

• 2 other identifiers: PeriSaFe01CIV-23-11-044875
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Appendicitis; Acute abdominal pain; Peritonitis; Medical Device; PERIsign

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects experiencing any adverse events during the examination

  Evaluation of there is any adverse events during the examination of the new diagnostic device.

  1 hour

• Proportion of device deficiencies during the evaluation

  Evaluation of there is any device deficiencies during the examination of the new diagnostic device.

  1 hour

Secondary Outcomes (2)

• To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system

  1 hour

• Proportion of examinations of the PERIsign system that its performed without usability issues.

  1 hour

Study Arms (2)

Patient Group

EXPERIMENTAL

Patient will be examined with the new device, PERIsign.

Device: PERIsign examination

Healthy Volunteers

ACTIVE COMPARATOR

The group will also be examined with the device, PERIsign

Device: PERIsign examination

Interventions

PERIsign examination DEVICE

Patients will be examined with the new device, PERIsign

Healthy Volunteers; Patient Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• STB INN AB: lead
• Aurevia: collaborator
• Region Halland: collaborator

Study Sites (2)

Hallands Sjukhus Halmstad

Halmstad, Sweden

Location

Hallands Sjukhus Varberg

Varberg, Sweden

Location

MeSH Terms

Conditions

Appendicitis; Abdominal Pain; Peritonitis; Abdomen, Acute

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Peritoneal Diseases

Study Officials

• Stefan Lindskog, ass. Prof

  Region Halland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: March 6, 2024
• Study Start: March 15, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)