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NCT06296953: PeriSaFe01
Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis
NA trial testing PERIsign examination in Appendicitis Acute in 40 participants. Completed in 1 August 2024.
1 August 2024
Quick facts
| Lead sponsor | STB INN AB |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 40 |
| Start date | 15 March 2024 |
| Primary completion | 1 August 2024 |
| Estimated completion | 1 August 2024 |
| Sites | 2 locations across Sweden |
Drugs / interventions tested
- PERIsign examination
Conditions studied
- Appendicitis Acute — all drugs for Appendicitis Acute →
- Appendicitis — all drugs for Appendicitis →
- Abdominal Pain — all drugs for Abdominal Pain →
- Peritonitis — all drugs for Peritonitis →
Sponsor
STB INN AB
Who can join
Adults 18 to 70, any sex, with Appendicitis Acute or Appendicitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06296953
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Appendicitis Acute
Currently open trials in the same condition.
- NCT07521969 — Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial. · NA · recruiting
- NCT06815822 — Prevention of Postoperative Hernias in Emergency Surgery · recruiting
- NCT06948071 — Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis · NA · recruiting
- NCT06762275 — The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care · NA · recruiting
- NCT06395636 — Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06296953 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by STB INN AB
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06296953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing