Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296953
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2024-02-10
Brief Title:
Safety Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
Sponsor:
STB INN AB
Organization:
STB INN AB
Study Overview
Official Title:
Safety and Feasibility of the PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeriSaFe01
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
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 patients 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 patients muscle activity and the pressure being applied to their abdomen PERIsign is connected to a laptop for data collection
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 patients 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 patients muscle activity and the pressure being applied to their abdomen PERIsign is connected to a laptop for data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-23-11-044875 | OTHER | Swedish Medical Product Agency | None |