Open/ Laparoscopic/ Robotic Resection of the Colon
Conditions
Keywords
Exero, anastomotic leak, impedance, ischemia, colon, bowel
Brief summary
The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.
Interventions
DEVICEExero Medical Leak Detection System
the Exero Leak Detection System components used in this study are: * Smart drain - a surgical drain with added sensing electrodes * Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem. * Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes.
Sponsors
Exero Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery. 3. Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.
Exclusion criteria
1. Subject has gastroparesis. 2. Subject has significant multisystem (autonomic) diseases. 3. Subject has a body mass Index greater than 35 kg/m2 4. Subject has an autoimmune disorder requiring therapy in the preceding 2 years. 5. Subject has significant cardiac arrhythmia or ectopy. 6. Obstructing lesion and pre obstruction bowel dilatation 7. Subject has an existing implanted electrical stimulator (e.g., pacemaker. 8. Subject requires chronic anticoagulant therapy 9. Subject is currently enrolled in other potentially confounding research. 10. Pregnancy 11. Current alcohol abuse 12. Subject poses a significant general anesthesia risk 13. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functionality of signal measurement | 10 minutes | Baseline data collected from the intended bowel segment to be resected, prior to tissue manipulation, is compared to the data recorded after the ischemia induced by the resection procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | 10 minutes | Adverse events both expected and unexpected, related or unrelated to study device or procedure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 |
Countries
Israel
Outcome results
None listed