Appendicitis AcutePeriSaFe01NCT06296953
Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
A study testing PERIsign examination in people with Appendicitis Acute and Appendicitis, run by STB INN AB at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis Acute, Appendicitis, Abdominal Pain
- What is being tested?
- PERIsign examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Mar 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 -
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Hallands Sjukhus Halmstad
Halmstad
Hallands Sjukhus Varberg
Varberg
About this study
Official title: Safety and Feasibility of the PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
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.
Read more
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
Read the detailed description
METHODOLOGY The PERIsign system is intended to aid physicians in demonstrating involuntary muscle defense as a sign of peritonitis by assessing involuntary activity in abdominal muscles by use of sEMG sensors and induced pressure.
In this investigation, all subjects will undergo examinations with the PERIsign system. For subjects with suspected appendicitis, assessments will be performed at the clinic on up to 2 occasions. An initial examination will occur when the patient is scheduled for surgery and admitted to the hospital. The following examination is optional and will occur 4-6 hours after the initial examination but before their planned surgery. Post-operative clinical assessments, patho-anatomical diagnosis and clinical end diagnosis will be collected from medical journals, 30 ±5 days after the initial examination. For the healthy volunteers, there is only 1 examination.
INVESTIGATIONAL MEDICAL DEVICE The PERIsign system is a medical device designed to measure the contractions of the internus and externus oblique muscles in the abdomen by use of surface electromyography (sEMG) sensors and induced pressure to facilitate the evaluation of a patient with acute abdominal pain. The PERIsign system aims to aid physicians in demonstrating involuntary muscle defense as a sign of peritonitis, an inflammation of the peritoneum, by measuring muscle activity both at rest and in response to pressure on the abdominal wall.
The PERIsign Minimal Viable Product is the first iteration of the device and will be used for the present clinical investigation. It comprises four sensor heads with connections, used together with single use sensor electrodes, that are applied to four specific locations on the patient's abdomen, and one reference electrode attached to the hand. Each sensor head has a pressure sensor on top that measures the pressure applied to the sensor, mimicking the manual palpation performed by a physician. The PERIsign system will display and record the patient's muscle activity and the pressure being applied to their abdomen. PERIsign is connected to a laptop for data collection.
- Conditions
- Appendicitis Acute, Appendicitis, Abdominal Pain, Peritonitis
- Being tested
- PERIsign examination
- Keywords
- Appendicitis, Acute abdominal pain, Peritonitis, Medical Device, PERIsign
- Medical subject headings
- Appendicitis, Abdominal Pain, Peritonitis, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERIsign examinationDevice
Patients will be examined with the new device, PERIsign
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Experimental | Patient will be examined with the new device, PERIsign. Receives: Device: PERIsign examination |
| Healthy Volunteers | Active comparator | The group will also be examined with the device, PERIsign Receives: Device: PERIsign examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Proportion of device deficiencies during the evaluation
Evaluation of there is any device deficiencies during the examination of the new diagnostic device.
Measured: 1 hour
Secondary outcomes (2)
To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system
During the evaluation the examiner interprets the graphical curves presented by the PERIsign system to evaluate and determine if there is an involuntary muscle defense at the subjects abdominal wall. The sensitivity and specificity will be calculated.
Measured: 1 hour
Proportion of examinations of the PERIsign system that its performed without usability issues.
The usability of the PERIsign system is tested by measuring how long the examination will take and how easy it is to use bye the examiner.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Mar 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- STB INN AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia, Region Halland
- Responsible party
- Sponsor
- Investigators
- Stefan Lindskog, ass. Prof, Principal investigator, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296953
- Sponsor's protocol ID
- PeriSaFe01
- Other IDs
- CIV-23-11-044875
- Acronym
- PeriSaFe01
- Status last verified
- Sep 2024
- First submitted
- 10 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
- ClinicalTrials.gov ID
- NCT06296953
- Acronym / sponsor ID
- PeriSaFe01 / PeriSaFe01
- Conditions
- Appendicitis Acute, Appendicitis, Abdominal Pain, Peritonitis
- Keywords
- Appendicitis, Acute abdominal pain, Peritonitis, Medical Device, PERIsign
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- STB INN ABIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia, Region Halland
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
METHODOLOGY The PERIsign system is intended to aid physicians in demonstrating involuntary muscle defense as a sign of peritonitis by assessing involuntary activity in abdominal muscles by use of sEMG sensors and induced pressure.
In this investigation, all subjects will undergo examinations with the PERIsign system. For subjects with suspected appendicitis, assessments will be performed at the clinic on up to 2 occasions. An initial examination will occur when the patient is scheduled for surgery and admitted to the hospital. The following examination is optional and will occur 4-6 hours after the initial examination but before their planned surgery. Post-operative clinical assessments, patho-anatomical diagnosis and clinical end diagnosis will be collected from medical journals, 30 ±5 days after the initial examination. For the healthy volunteers, there is only 1 examination.
INVESTIGATIONAL MEDICAL DEVICE The PERIsign system is a medical device designed to measure the contractions of the internus and externus oblique muscles in the abdomen by use of surface electromyography (sEMG) sensors and induced pressure to facilitate the evaluation of a patient with acute abdominal pain. The PERIsign system aims to aid physicians in demonstrating involuntary muscle defense as a sign of peritonitis, an inflammation of the peritoneum, by measuring muscle activity both at rest and in response to pressure on the abdominal wall.
The PERIsign Minimal Viable Product is the first iteration of the device and will be used for the present clinical investigation. It comprises four sensor heads with connections, used together with single use sensor electrodes, that are applied to four specific locations on the patient's abdomen, and one reference electrode attached to the hand. Each sensor head has a pressure sensor on top that measures the pressure applied to the sensor, mimicking the manual palpation performed by a physician. The PERIsign system will display and record the patient's muscle activity and the pressure being applied to their abdomen. PERIsign is connected to a laptop for data collection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | Experimental | Device: PERIsign examinationPatient will be examined with the new device, PERIsign. |
| Healthy Volunteers | Active comparator | Device: PERIsign examinationThe group will also be examined with the device, PERIsign |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Patient is 18-70 years of age
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERIsign examinationPatients will be examined with the new device, PERIsign | Device | Healthy Volunteers, Patient Group |
Primary outcome
Proportion of subjects experiencing any adverse events during the examination
Time frame: 1 hour
Evaluation of there is any adverse events during the examination of the new diagnostic device.
Proportion of device deficiencies during the evaluation
Time frame: 1 hour
Evaluation of there is any device deficiencies during the examination of the new diagnostic device.
2 secondary outcomes
To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system
Time frame: 1 hour
Proportion of examinations of the PERIsign system that its performed without usability issues.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Lindskog, ass. Prof principal investigator
Region Halland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERIsign examination in people with Appendicitis Acute and Appendicitis, run by STB INN AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects experiencing any adverse events during the examination (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.